PSC Biotech
Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it's about more than just a job-it's about your career and your future.
Your Role
We are hiring experienced CQV Engineers to support commissioning, qualification, and validation (CQV) activities across pharmaceutical and biotech facilities. This role involves planning, executing, and documenting CQV deliverables for equipment, utilities, and systems, while ensuring compliance with regulatory standards and industry best practices. • Develop and execute CQV protocols (IQ/OQ/PQ) for equipment, utilities, and systems. • Prepare and maintain comprehensive documentation: validation plans, protocols, reports, and SOPs. • Lead risk assessments and implement mitigation strategies for CQV activities. • Troubleshoot and resolve issues related to equipment and process performance. • Collaborate with cross-functional teams to ensure alignment on CQV deliverables and project timelines. • Ensure compliance with global regulatory standards (FDA, EMA) and industry best practices (GMP, ISPE Guides, Annex 15, PIC/S). • Support change management processes and field execution activities. • Contribute to continuous improvement and knowledge sharing across validation teams.
Requirements • Bachelor's degree in Engineering, Life Sciences, or a related field. • 5-10 years of CQV experience in pharmaceutical and/or biotech environments. • Minimum 3 years of hands-on experience with biologics API processing equipment and Cleaning Validation (CV), Clean-in-Place (CIP), and Steam-in-Place (SIP) systems. • Experience in CQV protocol development and execution (IQ/OQ/PQ). • Strong understanding of science- and risk-based CQV approaches, including ISPE Guides, Annex 15, and PIC/S. • Excellent communication, organization, and project management skills. • Detail-oriented with a strong commitment to quality and compliance. • Willingness to travel or relocate for project assignments.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
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 Holidays Education Assistance Pet Insurance Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more). Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), 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, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it's about more than just a job-it's about your career and your future.
Your Role
We are hiring experienced CQV Engineers to support commissioning, qualification, and validation (CQV) activities across pharmaceutical and biotech facilities. This role involves planning, executing, and documenting CQV deliverables for equipment, utilities, and systems, while ensuring compliance with regulatory standards and industry best practices. • Develop and execute CQV protocols (IQ/OQ/PQ) for equipment, utilities, and systems. • Prepare and maintain comprehensive documentation: validation plans, protocols, reports, and SOPs. • Lead risk assessments and implement mitigation strategies for CQV activities. • Troubleshoot and resolve issues related to equipment and process performance. • Collaborate with cross-functional teams to ensure alignment on CQV deliverables and project timelines. • Ensure compliance with global regulatory standards (FDA, EMA) and industry best practices (GMP, ISPE Guides, Annex 15, PIC/S). • Support change management processes and field execution activities. • Contribute to continuous improvement and knowledge sharing across validation teams.
Requirements • Bachelor's degree in Engineering, Life Sciences, or a related field. • 5-10 years of CQV experience in pharmaceutical and/or biotech environments. • Minimum 3 years of hands-on experience with biologics API processing equipment and Cleaning Validation (CV), Clean-in-Place (CIP), and Steam-in-Place (SIP) systems. • Experience in CQV protocol development and execution (IQ/OQ/PQ). • Strong understanding of science- and risk-based CQV approaches, including ISPE Guides, Annex 15, and PIC/S. • Excellent communication, organization, and project management skills. • Detail-oriented with a strong commitment to quality and compliance. • Willingness to travel or relocate for project assignments.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
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 Holidays Education Assistance Pet Insurance Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more). Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), 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, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
#LI-TP1