Validation Engineering Manager

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.

We are hiring an experienced and motivated Validation Engineering Manager to oversee project management, commissioning, and qualification activities for facilities, utilities, and computer systems. This role will drive successful project and deliverable completion adhering to industry standards and regulations.

• Complies with all policies, procedures, and laws.
• Examines manufacturer and blueprint specifications regarding electrical, mechanical, and software/computer systems to determine essential parameters.
• Develops Qualification Project Plans and protocols (IQ/OQ/PQ) to test essential installation, operation, and performance parameters for facilities, utilities, computer systems, or equipment.
• Protocols are approved through established channels; validation protocols are drafted and updated when required.
• Carries out validation and qualification protocols in accordance with applicable SOPs and confirms whether acceptance criteria are satisfied.
• Documents all test data in compliance with cGMP requirements.
• Prepares final reports and secures proper approval.
• Develops and communicates project timelines and status updates.
• Complies with GMP and safety standards, SOPs, and company policies and procedures.
• Performs related duties as assigned.
• Performs regular assessments of equipment and system qualifications, compiles comprehensive summary reports, and oversees the management of CAPAs for identified issues. Responsibilities include reviewing change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
• Prepares or updates Site Validation Master Plans.
• Develops and applies FMEAs, RCAs, and other investigative tools for failures and investigations.
• Performs risk assessments for qualification activities, change management, or quality investigations.

• Bachelor’s degree in engineering or related technical field.
• 5-7 years of experience within pharmaceutical or related manufacturing facility.
• Experience with manufacturing equipment functional parts including control systems, mechanical components, and electrical power.
• Strong understanding of regulatory requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to validation and computer systems.
• Strong technical expertise in computerized systems, automation, and digital analytics.
• Ability to write clear protocols, manage deviations, and communicate findings effectively.
• Experience with risk assessment methodologies (e.g., FMEA) and root cause analysis.
• Effective communication and interpersonal skills, enabling collaboration with diverse cross‑functional teams.
• 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…