CQV Engineer
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. <\/span>
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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 span>
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The Experience<\/b> <\/span>
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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 span>
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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 span>
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At PSC Biotech®, it’s about more than just a job—it’s about your career and your future span>
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Your Role<\/b> <\/span>
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We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and 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 span> <\/span>
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Develop and execute commissioning, qualification, and validation protocols for required equipment and systems span>
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Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures span>
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Identify and assess risks associated with CQV activities and develop effective mitigation strategies span>
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Troubleshoot and resolve issues related to equipment and process performance span>
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Collaborative with cross -functional teams to ensure alignment on CQV activities and project timelines span>
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Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.) span>
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Additional responsibilities as required to drive successful validation project deliverables span> <\/span>
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Requirements<\/h3>
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Bachelor’s degree in Engineering, Life Sciences, or a related field span> <\/span> <\/span>
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5+ years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries span> <\/span> <\/span>
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Strong knowledge of regulatory requirements and industry standards span> <\/span> <\/span>
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Experience with validation lifecycle management and risk -based approaches span> <\/span> <\/span>
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Excellent analytical and technical problem solving skills span> <\/span> <\/span>
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Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)<\/span> <\/span> <\/span>
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Effective communication and interpersonal skills span> <\/span> <\/span>
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Proactive with strong organization, time management, and project management abilities span> <\/span> <\/span>
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Excellent attention to detail with commitment to quality and compliance span> <\/span> <\/span>
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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 are essential, as it allows our team members to collaborate effectively with clients and colleagues nationally span> <\/span> <\/span>
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Must be authorized to work in the US span> <\/span> <\/span>
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No C2C at this time<\/span span span>
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Benefits<\/h3>
This is a full -time W2 temp position. W2 temp employees receive our medical and sick time benefits<\/span span div>
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Equal Opportunity Employment Statement<\/b span>
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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 span span>
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