Commissioning and Qualification Engineer
2 weeks ago
PSC Biotech is seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineer to support the commissioning, qualification, and validation of facility equipment and systems within the pharmaceutical and biotechnology industry.
Key Responsibilities
- Develop and execute commissioning, qualification, and validation protocols for plant equipment.
- Draft, review, author, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and more.
- Provide technical expertise throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
- Identify potential risks and areas of improvement and proactively implement risk mitigation.
- Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
- Collaborate with cross-functional teams to support project timelines and deliverables and drive successful validation of critical systems and equipment.
- Contribute to the continuous improvement of validation processes, procedures, and projects.
- Manage projects from initiation to completion, ensuring compliance with regulatory requirements and company standards.
- Ensure compliance with industry regulations and requirements at all times.
Requirements
- Bachelor's degree in a related engineering discipline.
- 3+ years of experience executing commissioning, qualification, and validation for a range of facilities equipment and systems within the pharmaceutical and/or biotechnology industries.
- Knowledge of regulatory requirements (cGMP, FDA, etc.).
- Experience working with HVAC and water systems preferred.
- Project Management experience or certification preferred.
- Excellent problem-solving, analytical, and technical skills.
- Strong time management and organizational abilities.
- Effective communication and interpersonal skills.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- Ability to work independently and as part of a team.
What We Offer
- Medical, Dental, and Vision - PSC pays 100% of all 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 Holiday.
- Education Assistance.
- Pet Insurance.
- Discounted Fitness/Gym Rates.
- Financial Perks and Discounts.
PSC Biotech is an equal opportunity employer and is committed to a policy of equal employment opportunity with respect to all employees, interns, and applicants for employment. 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.
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Los Angeles, California, United States PSC Biotech Full timePSC 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. We are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of facility equipment and systems within the...
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Los Angeles, California, United States PSC Biotech Full timeAbout the RoleWe are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of facility equipment and systems within the pharmaceutical and/or biotechnology industry.Key ResponsibilitiesLead the development and execution of commissioning, qualification, and validation protocols for plant equipment.Draft, review,...
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