Biotech Validation Jobs in Indiana (NOW HIRING)

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 a motivated CQV Engineer 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. Develop and execute commissioning, qualification, and validation 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. 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 Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences

1-3 years of validation experience within the pharmaceutical, biotech, or medical device industries. Strong knowledge of equipment and process validation in FDA-regulated environments. Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations.

Experience with cleanroom systems, HVAC, purified water, compressed air, and other critical utilities. Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports. Strong analytical and problem-solving skills.

Excellent written and verbal communication abilities. Strong time management and organizational skills. Detail-oriented mindset with a commitment to maintaining high-quality standards.

Must be authorized to work in the US. 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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