Biotech Validation Manager
5 days ago
We are a global company with operations spanning North America, Europe, Asia, and the Middle East. As a Validation Project Manager, you will work closely with our cross-functional teams to ensure that our clients' products meet the highest standards of quality and regulatory compliance.
The successful candidate will have a strong technical background in equipment/system validation, excellent communication, organization, and project coordinating capabilities. Responsibilities include developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.
About the Role:
- Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
- 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.
- Configure hardware, objects, SCADA systems, and field networks.
- Conduct risk analyses and identify potential risks, recommending areas of improvement.
- Identify, document, and manage deficiencies and deviations.
- Implement CAPA to resolve issues and prevent recurrence.
- 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.
- Additional responsibilities as required.
Requirements:
- Bachelor's degree in a related engineering discipline.
- 5+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
- Experienced in paperless validation, preferably ValGenesis.
- Proven success in managing, reviewing, authorizing, and approving full lifecycle technical documentation.
- Experienced in 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.
Salary: The estimated salary for this role is $120,000 - $150,000 per year, depending on location and experience.
Benefits: PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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