Validation Engineer

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 an experienced and driven Validation Engineer to support commissioning, qualification, validation, facility expansion, and design projects.

Successful candidates should have proven project management capabilities, a strong background in CQV processes, and knowledge of engineering specification documentation for facilities, utilities, and process equipment.

• Develop, execute, and review validation protocols for facilities, utilities, systems, and process equipment, ensuring compliance with regulatory requirements and industry standards.
• Support the development, writing, and review of specification documentation including URS, FS, and DS.
• Verify design drawings as required and provide technical design expertise as needed.
• Perform risk assessments and provide guidance and troubleshooting to mitigate potential validation issues. Implement corrective and preventative action.
• Prepare and maintain comprehensive validation documentation, including protocols, procedures, reports, risk analyses, change controls, reports, etc.
• Conduct factory acceptance testing.
• Assist and support construction control planning, coordinate vendors, proactively support in construction administration activities.
• Coordinate with cross-functional teams to ensure project objectives are met. Monitor project progress, making adjustments as necessary.
• Conduct regular reviews to assess project performance and identify areas for improvement. Implement change control processes to minimize project risks.
• Additional responsibilities as required to drive project success.

Requirements

• Bachelor's degree in related engineering discipline.
• 3-10 years of experience in commissioning, qualification, validation, facility expansion, and design projects within the pharmaceutical / life science industry.
• Proven success in project coordination / project management.
• Proven experience with facility and utility systems / equipment and process equipment.
• Excellent technical writing skills. Proven experience developing and reviewing technical documentation including protocols, procedures, and reports.
• Experienced and strong knowledge of user requirement specification, functional specifications, design specifications, etc.
• Experienced conducting factory acceptance testing.
• Experienced in project design support, ensuring that validation considerations are integrated into the design and implementation of new systems and processes.
• Advanced knowledge of industry regulations.
• Detail-oriented with a focus on ensuring compliance and quality.
• Excellent communication and interpersonal skills.
• Strong time management and organizational 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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Estimated Annual Salary (dependent on experience) $80,000 - $120,000.

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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Requirements

Bachelor's Degree in engineering or related. 3-6 years of experience of validation, commissioning, and qualification engineering experience in the pharmaceutical manufacturing industry.

Proven experience and success in developing specification documentation including URS, FS, DS, etc. Background in supporting construction projects.

Experienced conducting factory acceptance testing. Experienced in project design support, ensuring that validation considerations are integrated into the design and implementation of new systems and processes.

Experienced with utilities and process equipment (lyophilizers, chrome skids, controlled temperature units, tanks, bioreactors, etc.

Advanced knowledge of industry regulations. Experience with automation controls is a plus. Excellent communication and collaboration skills.

Detail-oriented with a focus on ensuring compliance and quality. 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.