Job Description Your RoleWe are seeking a Validation Engineer to support the validation of facilities, utilities, and equipment for a centrifuge implementation project within a regulated pharmaceutical or biotechnology environment. The successful candidate will be responsible for developing, executing, and documenting validation activities throughout the system lifecycle, ensuring compliance with applicable quality standards and regulatory requirements. The Validation Engineer will collaborate with cross-functional teams to support project execution from design qualification through commissioning, verification, and qualification activities.
- Support validation activities for facilities, utilities, and centrifuge equipment systems.
- Develop, author, review, and execute validation protocols and reports within the KNEAT platform.
- Support lifecycle validation deliverables from risk assessment through commissioning, qualification (IQ/OQ/PQ), and final verification.
- Collaborate with Engineering, Quality, Operations, and project teams to ensure validation deliverables are completed in accordance with project timelines.
- Execute field verification and qualification testing activities and document results.
- Identify, evaluate, and mitigate validation-related risks using a risk-based validation approach.
- Ensure validation documentation is complete, accurate, and compliant with cGMP and quality requirements.
- Support deviation investigations, change controls, and corrective actions associated with validation activities.
- Maintain compliance with client site training requirements, SOPs, and quality standards.
- Communicate project status, validation progress, and technical findings to project stakeholders.
- Support audits, inspections, and validation documentation reviews as required.
Requirements- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 3+ years of validation, CQV, or qualification experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
- Hands-on experience using KNEAT for validation protocol development, execution, and approval workflows required.
- Experience validating facilities, utilities, process equipment, and manufacturing systems.
- Strong understanding of validation lifecycle methodologies, including risk assessments, DQ, commissioning, verification, IQ, OQ, and PQ.
- Experience supporting centrifuges, process equipment, or similar manufacturing systems preferred.
- Working knowledge of cGMP regulations and industry guidance, including FDA and ISPE principles.
- Excellent technical writing, documentation, and protocol execution skills.
- Strong analytical, troubleshooting, and problem-solving abilities.
- Effective communication skills with the ability to work independently and within cross-functional team.
- Must be authorized to work in the U.S.
- No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
The salary bracket for this role is set between $90,000 - $105,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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