Validation Project Manager
3 weeks ago
PSC Biotech is a leading provider of life sciences services, ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. Our goal is to deliver exceptional results and support our clients' success.
The Role
- Collaborate with cross-functional teams to create and maintain project plans, scope requirements, and timelines, ensuring project milestones are met on time and within budget.
- Host project meetings to provide status updates to stakeholders and team members.
- Effectively communicate project findings, risks, and corrective action plans to stakeholders.
- Assess deviations and identify areas for improvement and associated action items.
- Conduct thorough technical evaluations of equipment and systems, identifying acceptance criteria, potential risks, and troubleshooting.
- Develop, review, and redline Piping and Instrumentation Diagrams (P&IDs) to ensure compliance with industry standards and regulations.
- Prepare and maintain detailed project documentation, including reports, risk assessments, and validation protocols.
- Collaborate with vendors to ensure equipment and system requirements meet project specifications.
- Assist with project closeouts and provide summaries/feedback for proposed process changes.
- Provide ongoing technical guidance, support, and execution throughout CQV and related projects.
Requirements
- Bachelor's Degree in a related engineering discipline.
- 5-10 years of validation project management experience in the pharmaceutical/biotech industry.
- Highly skilled in drafting, reviewing, and redlining P&IDs.
- AutoCAD experience is a plus.
- Strong understanding of industry regulations and quality standards.
- Strong understanding of the validation lifecycle in cGMP environments.
- Proven experience with asset management systems.
- Computer and technical software proficiency.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Excellent attention to detail and commitment to quality and compliance.
- Ability to work independently and manage multiple priorities.
Benefits
- PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.
- Opportunities for professional growth and development in a dynamic and supportive environment.
- Collaborative and inclusive team culture.
- Flexible work arrangements and remote work options.
- Competitive salary range: $85,000 - $125,000 annually.
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