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Validation Project Engineer II
2 months ago
PSC Biotech is seeking an experienced Validation Project Engineer II to drive successful project execution and completion in the pharmaceutical and life science industry. This role will involve handling document management, testing activities, and managing schedules, test materials, and vendor coordination.
Key Responsibilities- Document Management: Generate, revise, and manage validation lifecycle documentation, including user requirements, functional and design specifications, configuration specifications, computerized systems assessments, asset inductions, and validation protocols and required reports.
- Project Coordination: Generate and manage project plans, preventative maintenance coordination, and risk mitigation.
- Project Execution: Drive project success through efficient project coordination, managing schedules, test materials, and handling vendor coordination.
- Team Collaboration: Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
- Technical Expertise: Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
- Risk Management: Conduct risk analyses and identify potential risks, recommending areas of improvement.
- Compliance: Ensure compliance with industry regulations and requirements.
- Education: Bachelor's degree in a related engineering discipline.
- Experience: 3-5 years of commissioning, qualification, and validation engineering experience in the pharmaceutical/life science industry.
- Technical Skills: Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
- Communication Skills: Excellent technical writing skills and strong communication and interpersonal skills.
- Problem-Solving Skills: Strong problem-solving and analytical skills.
- Travel: Ability to travel as needed for project assignments and client engagements.
- Medical, Dental, and Vision: PSC Biotech pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
- Insurance Options: Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
- 401(k) and 401(k) Matching: PSC Biotech offers a 401(k) plan with company matching.
- PTO, Sick Time, and Paid Holidays: Generous paid time off and sick leave policies.
- Education Assistance: PSC Biotech offers education assistance to support employee growth and development.
- Pet Insurance: Discounted pet insurance rates for employees.
- Discounted Rate at Anytime Fitness: Employees receive a discounted rate at Anytime Fitness.
- Financial Perks and Discounts: PSC Biotech offers various financial perks and discounts to employees.
