Senior Validation Engineer Position
5 days ago
We are hiring a Senior Validation Engineer to join our team at PSC Biotech.
About the RoleThis is a W2 Temp position at 1-3 months with potential for extension. As a Senior Validation Engineer, you will be responsible for commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
- 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 mitigation strategies.
- Troubleshoot and resolve issues related to equipment and process performance.
- Support environmental monitoring requirements and related performance qualifications.
- Collaborate 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.).
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 10+ years of equipment commissioning, qualification, and validation engineering in the pharmaceutical and/or biotech industries.
- Proven expertise with sterilization process equipment.
- 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.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience. Our W2 Temp Positions include medical and sick time benefits.
PSC Biotech is committed to equal employment opportunity and prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment.
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