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PSC Biotech® Corporation · 3 days ago

Equipment Validation Engineer

Los Angeles, CA

Full-time

Hybrid

Mid, Senior Level

$85K/yr - $100K/yr

2+ years exp

PSC Biotech® Corporation provides essential services to the life sciences sector, ensuring healthcare products meet regulatory standards. They are seeking an Equipment Validation Engineer to develop and execute validation protocols, troubleshoot equipment, and generate lifecycle documentation critical for compliance in pharmaceutical manufacturing environments.

BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental

Growth Opportunities

No H1B

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

CommissioningQualificationValidation protocols (IQ/OQ/PQ)Regulatory requirements knowledgeTechnical documentation writingRisk-based validation approachPharmaceutical manufacturing experienceAnalytical 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

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

Willingness and ability to travel as needed for project assignments and client engagements