As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology.
We are seeking an experienced Validation Engineer in Dorado, Puerto Rico.
Objectives of this Role:
Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies.Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.Maintain an up-to-date knowledge of validation requirements, practices, and procedures.Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand.Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training.Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.Skills and Qualifications:
• More than 5 years of experience in the industry (preferably with experience in medical devices). • Experience executing semi-automatic equipment validations (Debug, IQ/SQ, Process Characterization, OQ/PQ, etc.). • Technical knowledge. • Knowledge of software and/or PLC is an advantage. • The candidate must be committed to the project and work in person daily. Distance should not represent a risk of abandoning the project early. • Willing to work overtime or weekends if necessary.Our Benefits:
Health, Dental, and Vision Insurance BenefitsTraining Opportunities and Career Development401k plan with Employer ContributionsPharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!
Read LessPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
PharmEng Technology aims to create a conducive work environment that fosters empowerment, passion, and perseverance while serving our clients to achieve their unique business goals.
Utilizes advanced skills to perform complex preventive maintenance and corrective repair of buildings, industrial systems, vehicles, equipment, and grounds. Working under limited supervision monitors building system operations and performance. Utilizes several trade skills such as carpentry, plumbing, electrical, painting, roofing, heating, and cooling.
We are looking for a Manufacturing Engineer to help us implement manufacturing processes that result in high-quality products.
You need to have a good knowledge of tool design and fabrication methods. Other necessary manufacturing engineer skills include project management ability, commitment to quality, and familiarity with safety and environmental standards. If you’re also inventive and meticulous, we’d like to meet you.
Ultimately, you’ll be the one to ensure our production lines work efficiently and effectively to satisfy our customers.
Responsibilities
Evaluate manufacturing processes based on quality criteria, such as efficiency and speed.Study production and machine requirements.Develop and test effective automated and manual systems.Design and install equipment.Organize and manage manufacturing workflows and resources.Integrate disparate systems (e.g. equipment handling, transport).Optimize facility layouts, production lines, machine operations, and network performance.Resolve issues and delays in production.Find ways to reduce costs and maximize quality.Train staff in new and existing processes.Collaborate with other engineers, contractors, and suppliers.Upgrade systems and processes with new technology.Requirements and skills
Previous experience as a manufacturing engineer Knowledge of manufacturing processes, fabrication methods, and tool design.Familiarity with manufacturing equipment and quality assurance techniques.Commitment to health and safety standards and environmental regulations.Experience in mechanical engineeringWorking experience with product lifecycle management (PLM), finite element analysis (FEA) and computational fluid dynamics (CFD)Hands-on experience with computer-aided engineering (CAM) and computer-aided manufacturing (CAE)Well-versed in relevant software (e.g. CAD, MS Office),Project management skills.Problem-solving ability.Teamwork skills.Degree in Engineering Read LessPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion, and perseverance are nurtured while serving our clients to achieve their unique business goals. Remote Position
Objectives of this Role:
Drawing up ideas for automated software testing procedures.Automating software programs and writing automation scripts.Designing and installing software databases.Troubleshooting software automation and finalizing system procedures.Identifying quality issues and creating test reports.Collaborating with the design team to resolve application problems.Programming new automation components.Writing reports and identifying quality issues.Implementing improvements in existing automation in machine assembly, machining, and inspection.Developing and implementing maintenance programs for equipment.Preparing manufacturing documentation.Coordinating projects.Assisting in the leadership of meetings with team members and hourly associates.Using tooling to manage gauge design and drawings.
Skills and Qualifications:
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion, and perseverance are nurtured while serving our clients to achieve their unique business goals.
Objectives of this Role:
Drawing up ideas for automated software testing procedures.Automating software programs and writing automation scripts.Designing and installing software databases.Troubleshooting software automation and finalizing system procedures.Identifying quality issues and creating test reports.Collaborating with the design team to resolve application problems.Programming new automation components.Writing reports and identifying quality issues.Implementing improvements in existing automation in machine assembly, machining, and inspection.Developing and implementing maintenance programs for equipment.Preparing manufacturing documentation.Coordinating projects.Assisting in the leadership of meetings with team members and hourly associates.Using tooling to manage gauge design and drawings.
Skills and Qualifications:
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
PharmEng Technology aims to create a conducive work environment that fosters empowerment, passion, and perseverance while serving our clients to achieve their unique business goals.
Utilizes advanced skills to perform complex preventive maintenance and corrective repair of buildings, industrial systems, vehicles, equipment, and grounds. Working under limited supervision monitors building system operations and performance. Utilizes several trade skills such as carpentry, plumbing, electrical, painting, roofing, heating, and cooling.
We are looking for a Manufacturing Engineer to help us implement manufacturing processes that result in high-quality products.
You need to have a good knowledge of tool design and fabrication methods. Other necessary manufacturing engineer skills include project management ability, commitment to quality, and familiarity with safety and environmental standards. If you’re also inventive and meticulous, we’d like to meet you.
Ultimately, you’ll be the one to ensure our production lines work efficiently and effectively to satisfy our customers.
Responsibilities
Evaluate manufacturing processes based on quality criteria, such as efficiency and speed.Study production and machine requirements.Develop and test effective automated and manual systems.Design and install equipment.Organize and manage manufacturing workflows and resources.Integrate disparate systems (e.g. equipment handling, transport).Optimize facility layouts, production lines, machine operations, and network performance.Resolve issues and delays in production.Find ways to reduce costs and maximize quality.Train staff in new and existing processes.Collaborate with other engineers, contractors, and suppliers.Upgrade systems and processes with new technology.Requirements and skills
Previous experience as a manufacturing engineer Knowledge of manufacturing processes, fabrication methods, and tool design.Familiarity with manufacturing equipment and quality assurance techniques.Commitment to health and safety standards and environmental regulations.Experience in mechanical engineeringWorking experience with product lifecycle management (PLM), finite element analysis (FEA) and computational fluid dynamics (CFD)Hands-on experience with computer-aided engineering (CAM) and computer-aided manufacturing (CAE)Well-versed in relevant software (e.g. CAD, MS Office),Project management skills.Problem-solving ability.Teamwork skills.Degree in Engineering Read LessPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
Job required Qualification:
Bachelor of Science degree, Engineering, or Equivalent training and experience.More than 5 years of experience in a regulated environment.3 years of experience authorizing procedural and commercial marketing documents.More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.Experience in mechanic and Industrial engineering Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.Strong relationship management, leadership, and organizational skills.Strong working knowledge in Microsoft suites, and Smartsheet.Job responsibilities and Duties:
Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).Develop and execute validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.Investigate and resolve deviations/exceptions from the predefined acceptance criteria.Draw conclusions from data, observations, deviation/exception, and investigation as to whether the process is considered valid.Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure.Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs.Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.Perform other related duties as assigned to meet departmental and Company objectives. Read LessPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
Data integrity specialists are responsible for ensuring that data is accurate and consistent across an organization. They commonly work with databases or other large pools of information, looking for errors or inconsistencies that may have been introduced during the collection, storage, or transmission process.
Responsibilities
Ensure the accuracy and completeness of data across multiple platforms through analysis, auditing, and reporting.Develop and maintain data integrity policies and procedures in alignment with organizational goals.Conduct regular audits of data to identify errors, discrepancies, or missing information.Investigate root causes of data issues and work with relevant teams to resolve them.Generate reports on data integrity findings for internal and external stakeholders.Keep abreast of new developments in data management and data integrity best practices.Train staff on data integrity procedures and policiesAssist with the development and implementation of data governance framework.Monitor compliance with data integrity policies and procedures.Escalate non-compliance issues to senior management as needed.Maintain up-to-date knowledge of relevant laws, regulations, and industry best practices.Perform other duties as assigned.Required Skills and Qualifications
Bachelor’s degree in computer science, information technology, or related field3-5 years professional experience working with Data Integrity Experience developing and implementing data quality control processes.Exceptional attention to detail and strong analytical skillsAbility to work independently and as part of a team.Proficient in Microsoft Excel and Access Read LessAs a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology.
We are seeking an experienced Validation Engineer.
Objectives of this Role:
Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies.Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.Maintain an up-to-date knowledge of validation requirements, practices, and procedures.Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand.Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training.Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.Skills and Qualifications:
Bachelor’s degree in engineering, life science discipline, or equivalent experience in the pharma/biotech industries.Highly capable of developing, executing, and reviewing validation life cycle protocols.Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.Experience with validation and working knowledge of production is a plus.Familiarity with FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).Experience with Microsoft Office Suite.Experience Programing LabView requirePharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!
Read LessProject Manager
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking a Project Management for an opportunity in Arizona on site.
In this role, you will be responsible for the cost-effective and timely procurement of production materials, supplies and services directly supporting our operations. The ideal candidate will have a proven track record of building strong partnerships with suppliers and internal stakeholders. Strong communication, negotiation, planning and problem-solving skills are essential to success in this role.
Responsibilities
Objectives of this Role:
Provide guidance, Lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the department.Assure projects are completed with approved scope, budget, schedule, and alignment with the master plan.Effectively interact with leadership and partner with Operations to establish priorities and define requirements for portfolio of projects within the assigned area.Ensure our capital investments use the best technology, have the best outcomes for our business, and align with contemporary standards.Serve as subject matter expert for one or more processing areas.Interface with engineering team to ensure project compliance with applicable client standards, follow all best practices and comply with client quality standards.Skills and Qualifications:
Bachelor of Science (BS degree in Engineering or related discipline from fully accredited institution.Minimum of 2 years in pharmaceutical experience. Experience in transferring products from one plant to another.Good working knowledge of Current Good Manufacturing Practices (cGMP) and facility/equipment validation requirements.Identify and research potential clients.Develop and maintain client relationships.Negotiate contract terms with clients and communicate with stakeholders.Excellent oral and written communication skills, including presentations.User level computer knowledge for completing documentation and email.Company Response to Covid-19
While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. When possible, PharmEng Technology will allow remote work from home.
EEOC Statement
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
Objectives of this Role:
Drawing up ideas for automated software testing proceduresAutomating software programs and writing automation scripts.Designing and installing software databasesTroubleshooting software automation and finalizing system procedures.Identifying quality issues and creating test reports.Collaborating with the design team to resolve application problems.Programming new automation componentsWriting reports and identifying quality issuesImplementing improvements in existing automation in machine assembly, machining, and inspection.Developing and implementing maintenance programs for equipmentPreparing manufacturing documentationCoordinating projectsAssisting in the leadership of meetings with team members and hourly associatesUsing tooling to manage gauge design and drawings
Skills and Qualifications:
Company Response to Covid-19
While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. When possible, PharmEng Technology will allow remote work from home.
EEOC Statement
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
