PSC Biotech® Corporation · 19 hours ago
Equipment Validation Engineer
PSC Biotech® Corporation provides essential services to the life sciences to ensure compliance with regulatory requirements. They are seeking a motivated Equipment Validation Engineer responsible for developing and executing validation protocols, troubleshooting equipment, and generating comprehensive lifecycle documentation for pharmaceutical manufacturing facilities.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
Responsibilities
Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ) for cleanroom environments and large process equipment
Write and review technical documentation including specifications (URS, FS, DS), SOPs, risk assessments, and final reports
Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations
Conduct impact, gap, and risk assessments to identify potential issues and implement mitigation strategies
Analyze test data and acceptance criteria to ensure accuracy and compliance
Operate and troubleshoot equipment during startup and validation phases to assess performance and recommend modifications
Ensure all validation activities meet current industry standards and regulatory requirements (cGMP, FDA, etc.)
Additional responsibilities as needed to support project deliverables
Qualification
Required
Bachelor's degree in Engineering or a related technical field
2 – 7 years of hands-on experience commissioning, qualifying, and validating process equipment within the pharmaceutical manufacturing industry
Experience qualifying cleanroom facilities
Experience in large process equipment in pharmaceutical manufacturing (vessels, centrifuges, filter presses and CIP skids)
Experienced writing and generating technical validation documentation including final summary reports, IQOQPQ protocols, specifications (URS, FS, DS), operating procedures, etc
Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.)
Strong understanding of risk-based validation approach
Excellent analytical, problem-solving, and communication skills
Ability to manage multiple projects and work both independently and collaboratively
Ability to work extended hours
Must be authorized to work in the US
No C2C at this time
Preferred
The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally
Candidates who are willing and able to travel as needed for project assignments and client engagements
Benefits
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
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
Funding
Current Stage
Growth StageRecent News
2025-12-18
2025-10-20
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