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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 an experienced Validation Engineer to drive project success and support the development and execution of commissioning, qualification, and validation protocols for a range of equipment and systems. Successful candidates should have a strong background and experience working with HVAC systems, and strong knowledge of risk based approaches in the pharmaceutical industry.
- Proactively support commissioning, qualification, and validation activities. Develop and implement comprehensive validation plans.
- Develop and execute CQV protocols for required equipment, facilities, utilities, systems, and processes, ensuring compliance with regulatory requirements and industry standards.
- Develop and execute validation protocols for required HVAC systems, including IQ, OQ, PQ. Conduct thorough risk assessment related to HVAC system validation.
- Investigate and troubleshoot HVAC system deviations, ensuring timely resolution and documentation of corrective actions.
- Write, review, and approve technical CQV documentation including standard operating procedures, validation plans, execution plans, risk assessments, summary reports, URS, FRS, design specifications, testing protocols, and so on.
- Conduct risk assessments to identify and mitigate potential validation risks. Support investigations, deviations, and change control processes.
- Collaborate with cross-functional teams to ensure alignment on project deliverables and timelines.
- Additional responsibilities as assigned.
Requirements
- Bachelor's Degree in related engineering discipline.
- 3-5 years of hands-on commissioning, qualification, and validation engineering experience in the pharmaceutical/life science industry.
- Experienced in pharmaceutical process equipment, facilities and utilities CQV including HVAC system qualifications.
- KNEAT system experience is highly preferred.
- Strong technical writing skills, experienced writing and executing validation protocols, reports, etc.
- Advanced understanding of validation principles and risk-based approaches.
- Strong knowledge of regulatory requirements and industry standards (cGMP, GDP, FDA, EMA, etc.)
- Proficiency in risk assessment methodologies and root cause analysis.
- Strong analytical and problem-solving skills, with a meticulous attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- 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.
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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Posted date: 2 days ago