Senior Validation Engineer (MS&T)

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

• Proactively lead validation activities for various CQV projects.
• Serve as an extension to MS&T team to support CQV processes in isolators, filling line, packaging process, VHP process, bioburden process, and extractable / leechables process.
• Responsible for protocol writing and execution - draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
• Commission, qualify, and validate facilities, utilities, and / or equipment in assigned projects.
• Initiate and coordinate risk analyses, design reviews, and execute FAT / SAT, IQ, OQ, and PQ.
• Conduct preventative maintenance and perform risk assessments.
• Recommend process improvements where needed ensuring compliance with industry standards.
• Develop validation master plans and validation summary reports.
• Develop and implement validation procedures, monitor equipment, and analyze test data.
• Establish validation standards and develop performance testing and quality control measures.
• Collaborate with multiple departments on assigned project activities and deliverables.
• Clearly communicate all progress, updates, and action steps for assigned projects.
• Additional responsibilities as assigned.

Requirements

• Bachelor's degree in engineering or related discipline.
• 7+ years of experience in validation engineering in the life science industry and cGMP environments.
• Proven success in a MS&T role and / or supporting MS&T projects.
• Experienced working in aseptic environment with strong knowledge of aseptic technique.
• Experience with facility startups and supporting CQV of process / manufacturing equipment.
• Ability to work on-site, must be local to Indianapolis, IN.
• Excellent communication skills, verbal and written.
• Ability to provide proactive followups and drive project completion.
• Strong problem solving and analytical skills.
• 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.

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
• Fitness Benefits (Membership discounts and other perks / services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
• Financial Perks and Discounts

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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Requirements

Bachelor's degree in engineering or related discipline. 7+ years of experience in validation engineering in the life science industry and cGMP environments.

Proven success in a MS&T role and / or supporting MS&T projects. Experienced working in aseptic environment with strong knowledge of aseptic technique.

Experience with facility startups and supporting CQV of process / manufacturing equipment. Ability to work on-site, must be local to Indianapolis, IN.

Excellent communication skills, verbal and written. Ability to provide proactive followups and drive project completion.

Strong problem solving and analytical skills. 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.