Job DescriptionJob DescriptionSalary:
ob Summary:
The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality standards. The role focuses on ensuring the effectiveness and consistency of cleaning processes, particularly for manufacturing equipment and related systems, including utilities and compressed air systems. The ideal candidate will bring expertise in cleaning validation, utilities qualification, and a strong understanding of GMP regulations.Responsibilities:Develop and implement cleaning validation protocols and reports, ensuring compliance with GMP, FDA, and other regulatory standards.Plan and execute cleaning validation activities for manufacturing equipment and utilities, including compressed air systems.Conduct risk assessments and identify critical control points for cleaning validation.Perform sampling and testing of cleaned equipment and utilities to ensure compliance with predetermined acceptance criteria.Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes.Develop and implement protocols for utilities qualification and monitoring, with a focus on compressed air systems.Analyze data to identify trends and recommend process improvements to enhance cleaning and utilities validation performance.Manage deviations and non-conformances related to cleaning validation activities, ensuring timely investigation and resolution.Maintain detailed and accurate documentation of cleaning validation and utilities qualification activities.Ensure the consistent implementation of cleaning validation processes across manufacturing operations.Support audits and inspections by regulatory authorities, providing expertise in cleaning validation and utilities processes.Stay current with industry trends and regulatory updates, ensuring continuous compliance and the adoption of best practices.Qualifications:Bachelors Degree in Engineering, Chemistry, Microbiology, or a related field.2+ years of experience in cleaning validation within a regulated manufacturing environment.Experience in utilities qualification, particularly compressed air systems.Strong knowledge of regulatory requirements, including GMP, FDA, and ICH guidelines.Proficiency in developing and executing cleaning validation protocols and reports.Demonstrated experience in risk assessment and data analysis for cleaning validation.Excellent problem-solving and analytical skills.Strong communication and interpersonal skills to collaborate with cross-functional teams and external auditors.Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management tools.Physical/Mental Requirements:Ability to work in a manufacturing environment, including cleanrooms and production areas.Able to stand for extended periods and climb ladders/steps as needed.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:
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:
Overview:Directly responsible for the execution of all automation assignments to fulfill our clients needs. Responsible for complex troubleshooting, and optimization for automation equipment, and applying advanced engineering principles to the design and implementation of new equipment.Responsibilities:
Execute multiple large, assigned projects according to our clients needs, within multiple sites.
Coordinate/oversee the development of new processes or troubleshoot existing ones.
Apply automation knowledge for manufacturing equipment applied to the pharmaceutical industry.
Manage day-to-day work with Software and Hardware production systems.
Use PLC and Stand-Alone systems.
Perform troubleshooting for manufacturing/production equipment and systems.
Perform all necessary engineering analysis and submit recommendations, as required.
Perform inspections of programs/equipment operation following established execution protocols.
Manage the deliverables to agreed schedule and scope of work.
Maintain excellent communications with upper management and colleagues of other functional areas to assure consistency with customer policies, procedures, and processes.
Participate in staff meetings, as requested, and provide periodical project status reports.
Troubleshooting and design multiple HMI SCADA software.
Troubleshooting and design multiple PLC software.
Assists, review and execute validations/qualifications documentation as per Standard Operating Procedures (SOPs) and regulatory guidelines.
Participates and provides expertise in developments/ improvements to automation programs as needed to remain current with the industry standards.
QUALIFICATIONS:
BS/BA degree in science, engineering, manufacturing technology, or closely related field is required.
Deep knowledge and over six years of experience in working Automation; PLC and Stand-Alone systems.
Knowledge of local access procedures, including but not limited to: Safety procedures, electronic systems access (email, phone, others).
Project management basic concepts: timeline follow-up, schedule reviews, predecessor.
People skills for interdisciplinary share.
Self-driven and schedule-oriented.
Strong skill in working independently and effectively interacting with various levels.
Experience with network and system administration of Microsoft-based systems, Visual Studio, ASP.Net, and SQL is preferred.
Demonstrated computer skills, including but not limited to, MS Excel, Word, PowerPoint, Project, and AutoCAD.
Proven ability to simultaneously manage multiple projects and initiatives.
Ability to work both independently and in partnership with others.
Bilingual: English and Spanish. Written and verbal.
PHYSICAL/MENTAL REQUIREMENTS
Able to stand for extended hours for test runs
May require extended working shifts.
Able to climb ladders/steps
Able to lift items of 25lbs
Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.
Moriah Engineering Solutions is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, military/veteran status, basis of genetic information, or any other group protected by law.
Job DescriptionJob DescriptionSalary:
OVERVIEWAs a Validation Specialist II you will be responsible for generating SDLC documentation and validating/qualifying the systems used to develop and/or manufacture products within our assigned client base. You will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.RESPONSIBILITESExecute multiple large, assigned projects within our clients needs.Coordinate the development of new processes or troubleshoot existing ones.Generates System Development Life Cycle documentation, including, but not limited to: Impact Assessments, User/Functional Requirements, Design/Functional Specifications, Traceability Matrix, ERES Assessments, Development Testing documents, Factory Acceptance Tests, Site Acceptance Tests, Installation and Operational Qualification Protocols, Commissioning documents, and ReportsSchedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.Coordinates and communicates all testing within company resources and affected functional groups and evaluates test results.Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.Participates and presents data in Customer, Corporation, and Internal audits.Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation.Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA)Apply validation knowledge for manufacturing/packaging/utilities equipment in the to pharmaceutical/medical device/ food and beverage industries.Perform all necessary engineering analysis and submit recommendations, as required.Create project documentation and procedures (SOP) to meet with customer requirements.Create acceptance criteria and conduct acceptance tests, if applicable.Manage the deliverables to agreed schedule and scope of work.Maintain excellent communications with upper management and colleagues of other functional areas to assure consistency with customer policies, procedures, and processes.Participate in staff meetings, as requested, and provide periodical project status reports.Any other duty assigned by supervisor, related to project, company or client needs.QUALIFICATIONSBS/BA degree in science, engineering, manufacturing technology or closely related field is required.Minimum of 3 years of relevant experience in validation is preferred.Excellent attention to detail and working knowledge of FDA Regulations/Guidance or Good Manufacturing Practices is required.Technical knowledge and experience with validation / qualification processes, equipment, utilities, facilities and/or computer systems is required.Must be proactive, have experience with high performance teams, strong interpersonal.Must be able to interact with varying levels within the company and customers.Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.Project management basic concepts: timeline follow up, schedule reviews, predecessor.People skills for interdisciplinary share.Self-driven and schedule oriented.Ability to evaluate compliance issues.Strong conflict resolution skills.PREFERRED QUALIFICATIONSValidation experience as related to sterile products, pharmaceutical products and medical devices is preferred.Interpretation of electrical drawings, P&ID, and network diagrams preferred.Validation certification preferred.HMI and PLC basic knowledge, preferred.PHYSICAL/MENTAL REQUIREMENTSMust be able to lift and carry light loads as necessary in conducting testing.May involve standing for long periods of time.May require extended working shifts.Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.Must be able to climb ladders/steps.Must be able to lift items of 25lbs.
Moriah Engineering Solutions is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, military/veteran status, basis ofgenetic information, or any other group protected by law.
