Validation Engineer II

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team's expertise to create a process design for our clients' products that best suits their needs.

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The Experience<\/b>

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With operations spanning the globe and featuring a multi-cultural team, BioTechnique 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 a 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 BioTechnique, it's about more than just a job-it's about your career and your future.<\/span>

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Your Role<\/b>

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BioTechnique is seeking a Validation Engineer II, with experience supporting validation and qualification activities in pharmaceutical, biotechnology, or sterile manufacturing environments. <\/span>

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The ideal candidate will have hands-on experience with facility and equipment qualification, cleanroom/airflow visualization studies, and autoclave validation. This role will work cross-functionally with Engineering, Facilities, Manufacturing, Microbiology, and Quality to execute validation activities in a fast-paced GMP manufacturing environment.<\/span>

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• Author and execute IQ/OQ/PQ protocols, validation plans, and summary reports.<\/span>

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• Support qualification and requalification of GMP facilities, utilities, manufacturing equipment, and cleanrooms.<\/span>

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• Support airflow visualization/smoke studies, including static and dynamic studies in aseptic environments.<\/span>

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• Perform autoclave qualification, including temperature mapping, heat penetration, leak testing, Bowie-Dick testing, biological indicators, and load qualification.<\/span>

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• Analyze validation and thermal mapping data and identify appropriate worst-case locations.<\/span>

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• Support equipment commissioning and qualification activities.<\/span>

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• Investigate validation discrepancies and support deviations, CAPAs, change controls, and impact assessments.<\/span>

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• Collaborate with Engineering, Facilities, Manufacturing, Quality, and Microbiology to ensure compliant and timely execution of validation activities.<\/span>

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• Maintain documentation in accordance with cGMP and Good Documentation Practices (GDP).<\/span><\/span>

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Requirements<\/h3>Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline.

<\/span><\/span><\/span><\/li>3-5 years of validation/CQV experience within pharmaceutical, biotechnology, biologics, or other regulated life-sciences manufacturing.

<\/span><\/span><\/span><\/li>Hands-on experience executing IQ/OQ/PQ protocols.

<\/span><\/span><\/span><\/li>Experience with facility, utility, and equipment qualification.

<\/span><\/span><\/span><\/li>Strong technical writing, troubleshooting, and data-analysis skills.

<\/span><\/span><\/span><\/li>Working knowledge of cGMP, GDP, deviations, CAPA, change control, and risk-based validation.

<\/span><\/span><\/span><\/li>Preferred Experience

<\/span><\/span><\/span><\/li>Airflow visualization/smoke studies in aseptic or ISO-classified environments.

<\/span><\/span><\/span><\/li>Steam sterilization/autoclave qualification and temperature mapping.

<\/span><\/span><\/span><\/li>Experience with thermocouples, biological indicators, Kaye, or similar validation systems.

<\/span><\/span><\/span><\/li>Cleanroom qualification and ISO 14644 experience.

<\/span><\/span><\/span><\/li>Experience with electronic validation/documentation systems such as Kneat or similar platforms.<\/span><\/span><\/span>

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Benefits<\/h3>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.

<\/span><\/span><\/div>Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents<\/span><\/span><\/span>

<\/li>Relocation assistance may be available depending on circumstances; details will be discussed during the interview process.<\/span>

<\/span><\/span><\/span><\/li>Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.<\/span>

<\/span><\/span><\/span><\/li>401(k) and 401(k) matching<\/span>

<\/span><\/span><\/span><\/li>PTO, Sick Time, and Paid Holidays<\/span>

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<\/span><\/span><\/span><\/li>Pet Insurance<\/span>

<\/span><\/span><\/span><\/li>Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)<\/span>

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<\/span><\/span><\/div>Equal Opportunity Employment Statement<\/b>

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<\/span><\/span><\/div>PSC 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>

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<\/span><\/span><\/div>#LI-DC1<\/span><\/span>

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