CQV Engineer

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the pharmaceutical manufacturing industry.

We are seeking a highly skilled CQV Engineer to join our team. As a CQV Engineer, you will be responsible for drafting, reviewing, and executing commissioning, qualification, and validation protocols for various equipment and systems.

• Draft, review, and execute commissioning, qualification, and validation protocols for a range of required equipment and systems.
• Schedule and execute qualification activities.
• Draft, review, author, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, operating procedures, URS, FRS, and so on.
• Document and report all validation activities and results, ensuring documentation updates as needed.
• Perform risk assessments and develop mitigation strategies for equipment and processes as required.
• Analyze test results, data, and acceptance criteria to ensure accuracy.
• Ensure all validation and qualification activities are completed in compliance with industry standards and regulations.
• Attend meetings and coordinate project activities.
• Collaborate closely with cross-functional teams to ensure alignment and successful project/deliverable execution.

• Bachelor's degree in a related engineering discipline.
• 3-5 years of commissioning, qualification, and validation experience in the pharmaceutical manufacturing industry.
• Hands-on experience with IQ, OQ, PQ execution, including equipment like chambers, refrigerators, fill lines, etc.
• Strong knowledge of aseptic process and techniques.
• Strong knowledge of industry regulations and requirements.
• Excellent technical writing skills and experience with full life cycle validation documentation.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving skills.

• Medical, dental, and vision insurance, with PSC Biotech paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for employee assistance programs, basic life insurance, short/long-term disability, and more.
• 401(k) and 401(k) matching.
• PTO, sick time, and paid holidays.
• Education assistance.
• Pet insurance.
• Fitness benefits, including membership discounts and other perks/services at qualifying gyms.
• Financial perks and discounts.

PSC Biotech is committed to a policy of equal employment opportunity and prohibits 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.