The Role
Provides Quality Assurance oversight for pharmaceutical, biotechnology, or medical-device validation documentation. Reviews and approves validation protocols, reports, risk assessments, deviations, investigations, CAPAs, and change controls. Ensures compliance with GMP, FDA, EU GMP, ICH, company procedures, and document-control requirements. Collaborates with Validation, Engineering, Manufacturing, and Quality teams to resolve deficiencies, supports audit and inspection readiness, and contributes to quality-system improvements.
Summary Generated by Built In
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
The Quality Engineer is responsible for providing Quality Assurance oversight of validation documentation and ensuring compliance with applicable GMP regulations, company procedures, and quality standards. This role focuses on the review, approval, and management of validation records to ensure documentation is accurate, complete, and inspection-ready. The ideal candidate will have experience supporting validation programs within a regulated pharmaceutical, biotechnology, or medical device environment and possess a strong understanding of quality systems and documentation controls.
- Perform QA review and approval of validation documentation.
- Ensure validation documents comply with internal procedures, GMP requirements, and applicable regulatory expectations.
- Review validation documentation for accuracy, completeness, traceability, and technical adequacy.
- Identify documentation deficiencies and collaborate with Validation, Engineering, Manufacturing, and Quality teams to resolve issues.
- Provide QA guidance regarding documentation requirements and quality compliance expectations.
- Review and approve quality system records associated with validation activities, including deviations, investigations, CAPAs, and change controls.
- Verify that validation deliverables are properly documented, approved, and maintained in accordance with document control requirements.
- Support audit and inspection readiness by ensuring validation records are complete and readily accessible.
- Participate in internal audits and regulatory inspections as needed.
- Assist with continuous improvement initiatives related to validation documentation and quality systems.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related scientific discipline.
- Minimum of 5 years of experience in Quality Assurance, Validation, or Validation Document Review within a regulated GMP environment.
- Demonstrated experience reviewing and approving validation documentation.
- Strong knowledge of validation lifecycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and change controls.
- Working knowledge of FDA, EU GMP, and ICH regulatory requirements.
- Experience with deviation management, CAPA, change control, and document management systems.
- Exceptional attention to detail and document review skills.
- Strong written and verbal communication skills.
- Ability to work independently while managing multiple priorities and deadlines.
- Must be authorized to work in the U.S.
- 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
The salary bracket for this role is set between $110,000 - $120,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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.
#LI-JD1
Skills Required
- Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related scientific discipline
- Minimum of 5 years of experience in Quality Assurance, Validation, or Validation Document Review within a regulated GMP environment
- Experience reviewing and approving validation documentation
- Knowledge of validation lifecycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and change controls
- Working knowledge of FDA, EU GMP, and ICH regulatory requirements
- Experience with deviation management, CAPA, change control, and document management systems
- Exceptional attention to detail and document review skills
- Strong written and verbal communication skills
- Ability to work independently while managing multiple priorities and deadlines
- Must be authorized to work in the United States
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
