Validation Project Manager
3 weeks ago
PSC Biotech is seeking an experienced Validation Project Manager to join our team. This role will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.
Key Responsibilities:- Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
- Generate and manage project deliverables, preventative maintenance coordination, and risk mitigation.
- Define and monitor Key Performance Indicators (KPIs) to measure validation effectiveness and report on KPIs to management and stakeholders.
- Oversee validation projects from initiation to completion.
- Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
- Conduct dry-runs, review, approve, and execute validation documentation.
- Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
- Implement and review audit trails to ensure data integrity.
- Provide ongoing support and technical expertise through validation execution and qualification activities.
- Conduct risk analyses and identify potential risks, recommending areas of improvement.
- Design, develop, and optimize terminal sterilization cycles for pharmaceutical products.
- Identify, document, and manage deficiencies and deviations.
- Perform risk assessments to identify critical process parameters and develop mitigation strategies.
- Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.
- Bachelor's degree in related engineering discipline.
- 8+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
- Strong knowledge of terminal sterilization processes, cycle development, performance qualification and process qualification preferred.
- Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
- Experienced generating and executing validation activities on a range of equipment and systems.
- Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
- Experienced in vendor coordination.
- Excellent technical writing skills.
- Strong understanding of industry regulations and requirements.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
PSC Biotech is an equal opportunity employer and welcomes applications from diverse candidates. We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.
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Validation Project Manager
1 month ago
Durham, North Carolina, United States PSC Biotech Corporation Full timeAbout the RolePSC Biotech Corporation is seeking an experienced Validation Project Manager to join our team. As a key member of our engineering team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key ResponsibilitiesDevelop and implement validation plans, protocols, and...
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Validation Project Manager
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Durham, North Carolina, United States PSC Biotech Full timeJob DescriptionPSC Biotech is a leading provider of life sciences services, ensuring the development, manufacturing, and distribution of healthcare products meet the highest standards and regulatory requirements.We are seeking an experienced Validation Project Manager to join our team. The successful candidate will have a strong technical background in...
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Validation Project Manager
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Durham, North Carolina, United States PSC Biotech Full timePSC Biotech is seeking an experienced Validation Project Manager to join our team. As a key member of our engineering team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key responsibilities include:Developing and implementing validation plans, protocols, and reports for...
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Validation Project Manager
3 weeks ago
Durham, North Carolina, United States PSC Biotech Full timePSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.We are seeking an experienced Validation Project Manager to join our team, responsible for developing and implementing validation plans, protocols, and...
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