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Validation Engineer
2 months ago
PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.
Job SummaryWe are seeking a highly skilled Validation Engineer to join our team. As a Validation Engineer, you will play a critical role in ensuring the successful execution of commissioning, qualification, and validation of laboratory equipment, facility systems, and utilities.
Key Responsibilities- Develop and execute commissioning, qualification, and validation protocols for laboratory equipment, facility systems, and utilities.
- Prepare and review validation documentation, including protocols, reports, master plans, risk assessments, procedures, and so on.
- Perform hands-on testing and analysis during qualification and validation tasks.
- Participate in risk assessments and impact assessments, and support troubleshooting and risk resolution.
- Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
- Perform temperature mapping studies for controlled environments, lab spaces, warehouses, CTUs, and so on.
- Collaborate with cross-functional teams to support project timelines and deliverables.
- Contribute to the continuous improvement of validation processes and procedures.
- Ensure compliance with industry regulations and requirements.
- Bachelor's degree in a related engineering discipline.
- 2+ years of experience in a validation role, having executed CQV protocols for a range of laboratory equipment, facilities, and utilities.
- Experience with temperature mapping procedures and activities.
- Proficiency with paperless validation systems (ValGenesis, KNEAT, etc.).
- Experience with controlled systems.
- Strong understanding of regulatory requirements, including cGMP, FDA, and so on.
- Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- Medical, dental, and vision insurance, with 100% coverage for employees and 50% coverage for dependents.
- Insurance options for employee assistance programs, basic life insurance, short-term and long-term disability, and more.
- 401(k) and 401(k) matching.
- PTO, sick time, and paid holidays.
- Education assistance.
- Pet insurance.
- Discounted rate at Anytime Fitness.
- Financial perks and discounts.
PSC Biotech is committed to a policy of equal employment opportunity, and we prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer-sponsored activities and programs.
