Job DescriptionJob DescriptionSalary:
We are seeking an experienced IT/ Automation Specialist to support the operation and/or capital projects
in the following key activities or tasks (but not limited to) the support services:
Ensures the continue operations of all Process Equipment including programming and
ongoing maintenance for Manufacturing and Utilities Areas.
Provides technical support during installation, configuration, integration, troubleshooting,
maintenance, qualification and upgrade for new and existing computerized systems in
Manufacturing and Utilities Areas (systems include and not limited to PLCs, HMI, Delta V,
Factory Talk, SCADA, DCS/BAS, communication interfaces, networking, printers, report
engines, databases and MES system).
Perform software or hardware changes to automation and computerized systems by
developing analysis, recommending improvements to existing processes through the use
of state-of-the-art computer technology.
Participates proactively as a team member of implementation projects for new integrated
business application and processes automation, providing consulting advice in the use
and management of technology.
Installs, configures, troubleshoots, and maintains computerized systems in Manufacturing
and Utilities Areas. These systems include (not limited to), PLCs, SCADA, and Fourth
generation languages for interfaces and report development.
Provides user training and continuous support to assure proper use of the software
applications following established operational procedures and user support during
problem solving situations associated with systems implementation.
Reviews and test programs to ensure that they meet manufacturers recommend
requirements for hardware and software at the personal computer and/or host computer
system level. Perform changes to applications or to their corresponding configurations to
assure software works as expected before installing it in the user environment.
Evaluates and closes change control requirements and documentation assuring the
validated and compliance state of the environments.
Assist on quality events investigations, internal audits, CAPA and standalone processes
related Manufacturing/Engineering/Laboratory computerized systems, MES related
applications and systems.
Provides project status using project plans and perform best efforts to achieve projects
milestones within the pre-established due dates. Provides alternatives and problem
solving initiatives during possible project delays or possible showstoppers.
Support the standards or strategy definition for software automation, system integration,
minimum requirements for plant automation through analysis and design/re-design of
current systems and processes.
Develops and/or reviews automation and computerized system related procedures such
as: Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery.
Contacts hardware or software vendors (if applicable) to report or address problems.
Coordinate and implement vendor recommendations.
Assures reported problems are solved by implementing corrective actions like (but not
limited) user retraining, changes to existing SOPs, applying software fixes or hardware
fixes, Information Resources colleagues recommendations, etc. These activities must
comply with current applicable change control procedures.
Completes CAPAs, standalone actions, assessments required as part of Quality Systems
and/or Reliability program related to automation and computerized systems.
Assist in the management of Capital Appropriation Requests (CARs), and timeline of
process automation projects and implementation and support Process Automation
initiatives.
Provides necessary support for Data Integrity and Cyber Security program and initiatives
Support in the execution of the Computer System Validation (CSV) program for automated
and computerized systems processes.
Keeps abreast with current technology.
Resources Qualifications
BS in electrical, computer, mechanical engineering and or related fields.
Five-(5) years of experience in pharmaceutical operations or Manufacturing processes
with proven project management skills which four (4) of the five years experience, must
be in Process automation in pharmaceutical environment with two (2) years experience
in computerized systems validation.
Proficient knowledge of computer system life cycle concepts, change control systems and
FDA regulatory requirements, including 21 CFR Part 11.
Proven experience issuing and preparing Computerized Functional Requirements and
Design Specifications.
In-depth knowledge of the science and physics involved in the design, installation,
commissioning and validation/qualification of computerized systems and PLCs as applied
to pharmaceutical production environment.
Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining
to a biopharmaceutical manufacturing plant.
Experience with external and internal regulatory audits (FDA, EMA, Otsuka, Sanofi, etc.).
Knowledge of pharmaceutical business processes and equipment.
Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
Proven skills in projects management, systems development and implementation of
manufacturing, MES Systems, and quality related systems.
Ability to manage and operate computer software packages used for data acquisition
systems and PLC programming, including (not limited to) Rockwell Automation platform
visualization and programming solutions/tools.
Knowledge of data historian (including, but not limited to OSI PI-FactoryTalk Historian),
Databases (MS SQL) and networking infrastructure and topologies.
Significant abilities and aptitude to analyze data detecting inconsistencies, determining
relative importance and to solve complex technical situations based on data.
Bilingual English/Spanish, both written and verbal are required.
Able to interact effectively with people to establish and maintain excellent working
relationship with internal and external customers at all organizational levels and
disciplines in such a way to facilitate the validation/qualification work.
Able to plan and prioritize multiple complex activities simultaneously (i.e., installation,
integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
Self-starter and well organized.
Ability to keep work pace and/or meet deadlines.
Ability to exercise good judgment.
Preferred:
Experience with CMMS (Maximo) system preferred.
High degree Knowledge and experience in Rockwell Automation Platforms
Knowledge and experience in Siemens systems.
Knowledge and experience in Wonderware software.
Knowledge and experience with virtualization software VMWare vSphere.
Knowledge and experience with Microsoft SQL Database.
Knowledge and experience in OSI Soft AVEVA PI System.
Knowledge and experience in Factory Talk Batch.
Knowledge and experience in MES Syncade system.
About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.
Job DescriptionJob DescriptionSalary:
Position Summary:
We are looking for a detail-oriented Project Coordinator to manage and oversee validation, manufacturing, and utilities projects in the pharmaceutical industry. This role involves planning, executing, and delivering projects within set timelines, ensuring compliance with industry regulations and company standards. The ideal candidate will be skilled in coordinating cross-functional teams, managing resources effectively, and maintaining strong documentation practices.Responsibilities:Project Management: Coordinate pharmaceutical-related projects, including process validations, equipment implementation, and change control, ensuring timely and successful execution.Documentation and Compliance: Develop, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in compliance with cGMP and FDA regulations.Communication and Coordination: Act as the primary point of contact for cross-functional teams, facilitating meetings, providing project updates, and ensuring effective communication between all stakeholders.Resource Management: Oversee and coordinate internal and external resources, schedule validation activities, and manage vendor relationships as needed.Analysis and Continuous Improvement: Analyze validation study data, prepare detailed reports, and propose process and procedural improvements to enhance operational efficiency and quality.Requirements:Education: Bachelors degree in a related field.Experience: 3-5 years of experience in the pharmaceutical industry, focusing on project management, validation, and cGMP compliance.Technical Skills: Knowledge of pharmaceutical manufacturing processes, equipment validation, and familiarity with FDA and cGMP regulations.Competencies: Excellent verbal and written communication skills, strong analytical abilities, and the ability to manage multiple projects simultaneously.Certifications: CAPM or PMP certification is a plus.Position Details:Employment Type: Contractor.Location: Jayuya. P.R.
Job DescriptionJob DescriptionSalary:
Job Summary:
The Validation Specialist Utilities is responsible for developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards. This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air, HVAC, and clean steam. The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations.Responsibilities:Develop, execute, and maintain validation protocols and reports for utility systems, including water systems, compressed air, HVAC, and clean steam.Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Perform risk assessments to identify critical control points and ensure compliance with GMP and regulatory standards.Monitor and evaluate the performance of utility systems to ensure consistent operation within validated parameters.Collaborate with cross-functional teams, including Engineering, Quality Assurance, and Manufacturing, to define validation requirements and strategies.Develop and implement protocols for periodic review and requalification of utilities systems.Analyze validation data to identify trends and recommend improvements to utility system performance and compliance.Manage deviations and non-conformances related to utility system validation, ensuring timely investigation and resolution.Provide support during regulatory audits and inspections, offering expertise in utilities validation and compliance.Maintain detailed and accurate documentation of all validation activities and changes to utility systems.Stay current with industry trends and regulatory updates, ensuring compliance and best practices in utilities validation.Qualifications:Bachelors Degree in Engineering, Life Sciences, or a related field.2+ years of experience in utilities validation within a regulated manufacturing environment.Strong knowledge of GMP, FDA, and ICH guidelines.Demonstrated expertise in validating utility systems such as water systems, compressed air, HVAC, and clean steam.Experience in risk assessments, validation protocols, and data analysis.Proficiency in developing and executing IQ, OQ, and PQ protocols.Strong problem-solving and analytical skills.Excellent communication and interpersonal skills for cross-functional collaboration.Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management software.Physical/Mental Requirements:Ability to work in manufacturing environments, including cleanrooms and utility areas.Able to stand for extended periods and climb ladders/steps as required.Ability to lift and move items up to 25 lbs.About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.
Job DescriptionJob DescriptionSalary: $20
Position Summary:
We are seeking five (5) Chemist Level 2 candidates to join our pharmaceutical manufacturing team. The Chemist Level 2 will handle advanced analytical testing, oversee laboratory operations, and play a critical role in supporting quality assurance initiatives.Key Responsibilities:Perform complex analytical testing and method development for raw materials, in-process samples, and finished products.Lead investigations and root cause analyses for quality events, deviations, and non-conformances.Participate in validation activities, including method validations and equipment qualifications.Ensure compliance with cGMP regulations, company policies, and laboratory standards.Mentor and guide junior chemists, providing technical support as needed.Maintain LIMS data accuracy and ensure effective documentation of laboratory results.Preferred Qualifications:Bachelors degree in Chemistry or related field (Masters degree preferred).Preferred: Valid Chemist License (Licencia de Qumico).Preferred: Advanced experience with Laboratory Information Management Systems (LIMS).Preferred: Extensive experience with validation activities in a pharmaceutical environment.Skills and Competencies:Proficient in advanced laboratory techniques and instrumentation.Strong problem-solving and analytical skills.Deep understanding of regulatory requirements (GMP, FDA, etc.).Excellent communication and leadership abilities.If you meet the qualifications and are ready to contribute to a dynamic team, we encourage you to apply.
