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 Validation Engineers responsible for supporting Commissioning, Qualification, Validation, and Computer Systems Validation (CSV) activities for facilities, utilities, equipment, and associated computerized systems within the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success by supporting validation planning, documentation, execution, and lifecycle compliance while ensuring regulatory, quality, and data integrity requirements are met.

• Develop and execute commissioning, qualification, validation, and CSV protocols for facilities, utilities, manufacturing equipment, and equipment-based computerized systems.
• Author, review, and maintain validation lifecycle documentation including validation plans, protocols (IQ/OQ/PQ), test scripts, reports, risk assessments, and SOPs.
• Perform and support equipment-based CSV activities, including system classification, risk assessments, Part 11/Annex 11 assessments, and data integrity evaluations.
• Ensure proper integration and validation of computerized systems interfacing with manufacturing equipment and utilities.
• Identify, assess, and mitigate risks associated with CQV and CSV activities using risk-based approaches.
• Support troubleshooting and resolution of issues related to equipment performance, system functionality, and validation deviations.
• Collaborate with cross-functional teams including Engineering, Quality, Manufacturing, Automation, and IT to align validation activities with project timelines and objectives.
• Ensure compliance with applicable regulatory requirements and industry standards (FDA, EMA, cGMP, GAMP 5, 21 CFR Part 11, Annex 11).
• Support audits, inspections, change controls, deviations, CAPAs, and periodic reviews as applicable.
• Additional responsibilities as required to drive successful validation project deliverables.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 3-5 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
• Strong knowledge of regulatory requirements and industry standards.
• Experience with validation lifecycle management and risk-based approaches.
• 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 are essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• Must be authorized to work in the U.S.
• No C2C at this time.

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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC Biotech 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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