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Lead Validation Engineer
2 months ago
PSC Biotech stands at the forefront of providing critical services to the life sciences sector, ensuring that the development, manufacturing, and distribution of healthcare products adhere to the highest quality benchmarks and regulatory standards.
Your Responsibilities
- Oversee the formulation and implementation of commissioning, qualification, and validation protocols for laboratory apparatus and facility systems.
- Draft, evaluate, and implement validation documentation.
- Offer technical guidance throughout the validation process.
- Recognize potential risks and execute risk management strategies.
- Record test outcomes in accordance with company protocols.
- Conduct temperature mapping assessments.
- Work collaboratively with interdisciplinary teams.
- Enhance validation processes through continuous improvement initiatives.
- Ensure adherence to industry regulations.
- Bachelor's degree in a relevant engineering field.
- 7-10 years of validation experience within the life sciences domain.
- Familiarity with validation protocols for laboratory instruments.
- Experience with digital validation systems.
- Project Management experience is advantageous.
- Strong understanding of controlled systems and risk-based validation methodologies.
- Exceptional communication and interpersonal abilities.
- Meticulous attention to detail with a strong commitment to quality standards.
- Comprehensive Medical, Dental, and Vision coverage.
- Insurance options along with 401(k) matching.
- Paid Time Off, Sick Leave, Paid Holidays, and Educational Assistance.
- Pet Insurance and Wellness Benefits.
- Financial Incentives and Discounts.