Validation Professional
2 days ago
PSC Biotech offers a range of services to the life sciences industry, including commissioning, qualification, and validation of facilities, utilities, and equipment. We are currently seeking an experienced Validation Engineer to join our team.
Responsibilities:- Develop and implement 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.
- 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.
- Minimum of 2 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.
$85,000 - $110,000 per year, depending on experience.
Work Environment:PSC Biotech operates globally, with offices located in North America, Europe, Asia, and the Middle East. This position requires travel to client sites and may involve working in different locations and environments.
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