Job DescriptionPSC 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 ExperienceWith 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 decide 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 RoleWe are seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineer to support capital projects at a medical device manufacturing facility. This role will be responsible for executing CQV activities associated with new and existing equipment, systems, and facility improvements. The ideal candidate will bring at least five years of dedicated CQV experience and be comfortable supporting multiple capital projects in a regulated manufacturing environment.
This is a 6-month W2 temp contract opportunity based in Columbia, MO, with potential for extension. Applicants must be legally authorized to work in the United States. Employer-sponsored work authorization is not available for this position, and Corp-to-Corp (C2C) arrangements will not be considered.- Plan, coordinate, and execute commissioning, qualification, and validation activities supporting capital projects.
- Develop, review, and execute CQV documentation and protocols for equipment, systems, and facility-related projects.
- Support qualification activities throughout the project lifecycle, including installation, operational, and performance qualification, as applicable.
- Review project documentation to ensure systems and equipment meet defined specifications and validation requirements.
- Identify, document, and support the resolution of discrepancies, deviations, and qualification-related issues.
- Collaborate with Engineering, Quality, Manufacturing, and other cross-functional stakeholders to support successful project execution.
- Maintain accurate and complete CQV documentation in accordance with applicable quality and documentation requirements.
- Support multiple capital projects and adapt CQV activities based on project scope, priorities, and timelines.
- Provide technical CQV expertise and independently manage assigned qualification activities.
Requirements- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 5+ years of professional CQV experience within a regulated manufacturing environment.
- Demonstrated hands-on experience with commissioning, qualification, and validation activities.
- Experience supporting capital projects involving manufacturing equipment, systems, facilities, or utilities.
- Strong experience developing, reviewing, and executing CQV protocols and associated documentation.
- Ability to independently manage CQV deliverables and work effectively within cross-functional project teams.
- Strong technical writing, documentation, organization, and problem-solving skills.
- Experience within the medical device industry or a similarly regulated environment preferred.
- Must be authorized to work in the U.S.
- No C2C at this time.
BenefitsW2 Temp roles include our Medical and Sick Time benefits
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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