CQV Engineer

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 teams 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 its about more than just a jobits about your career and your future.

Your Role

We are hiring CQV Engineers (I II III IV) of varying experience responsible for the commissioning qualification and validation for facilities utilities and process equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success while supporting validation planning development documentation and execution and ensuring regulatory standards and quality requirements are met.

• Develop write and execute IQ OQ PQ protocols for required equipment and systems.
• Prepare and maintain comprehensive documentation including validation protocols plans reports and standard operating procedures.
• Identify and assess risks associated with CQV activities and develop effective mitigation strategies. Support deviation resolution change control assessments and CAPA activities.
• Troubleshoot and resolve issues related to equipment and process performance.
• Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.
• Ensure compliance with regulatory requirements (FDA EMA etc.) and industry standards (GMP GAMP etc.).
• Additional responsibilities as required to drive successful validation project deliverables.

Requirements

Benefits

W2 Temp positions 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 applicants employees or interns 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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Required Skills :

Bachelors degree in Engineering Life Sciences or a related field. Proven experience in equipment commissioning qualification and validation engineering experience in the pharmaceutical manufacturing industry. Strong knowledge of regulatory requirements and industry understanding of risk-based validation and full life cycle approach. Experience qualifying large process equipment and supporting utilities (i.e. vessels CIP / SIP skids isolators autoclaves WFI clean steam etc.) Cell and gene therapy experience preferred. Experienced with paperless validation systems i.e. Kneat Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols reports procedures risk assessments specifications and requirements etc.) Effective communication and interpersonal skills. Proactive with strong organization time management and project management abilities. Excellent attention to detail with commitment to quality and compliance. At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time

Key Skills

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Employment Type : Full Time

Experience : years

Vacancy : 1