Senior Validation 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 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

• Review and evaluate existing protocols
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects
• Experience in authoring, revising, reviewing, and completing controlled documents for validation projects
• Conduct system impact assessment (SIA) to determine direct and indirect impact status of identified systems
• Supports writing and reviewing GMP and GDP documents and technical specifications
• Collaborate with multiple departments on assigned project activities and deliverables
• Assist to initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ
• Additional duties and responsibilities may be assigned from time to time

Requirements

• 5+ years of validation experience in the biotechnology industry
• Experience generating design specifications (URS, FS, DS)
• Experience with system impact assessment and risk assessment
• Experienced in facility/utility/equipment CQV
• Experience developing SOPS, final reports, and validation & quality documentation
• Strong understanding of CGMP guidelines
• Excellent Technical Writing skills
• Ability and willingness to travel is highly preferred

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 AnytimeFitness
• Financial Perks and Discounts

Annual Salary Range (dependent on experience) $135,000 - $142,000

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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