Validation Engineer
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Apply Now Application ends in 27d 17h 1min
Job Detail
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Offered Salary 0
Job Description
Your Role
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We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension. We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.
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- Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
- Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
- Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
- Troubleshoot and resolve issues related to equipment and process performance.
- Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.
- Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
- Additional responsibilities as required to drive successful validation project deliverables.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 3-5 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
- Strong knowledge of regulatory requirements and industry standards.
- Experience with validation lifecycle management and risk-based approaches.
- Excellent analytical and technical problem solving skills.
- Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
- Effective communication and interpersonal skills.
- Proactive with strong organization, time management, and project management abilities.
- Excellent attention to detail with commitment to quality and compliance.
- At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. 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.
Apply Now
Application ends in 27d 17h 1min