Equipment Validation Engineer jobs in United States
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PSC Biotech® Corporation · 3 months ago

Equipment Validation Engineer

PSC Biotech® Corporation provides essential services to the life sciences, ensuring healthcare products are developed and distributed to high standards. The Equipment Validation Engineer will be responsible for commissioning, qualifying, and validating pharmaceutical manufacturing facilities and equipment, ensuring compliance with regulatory requirements and industry standards.

BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
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Growth Opportunities
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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

CommissioningQualificationValidationPharmaceutical manufacturingRegulatory requirementsRisk-based validationTechnical documentationAnalytical skillsProblem-solving skillsCommunication skillsProject management

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

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

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Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.

Funding

Current Stage
Growth Stage

Leadership Team

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John Clapham
CEO
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Company data provided by crunchbase