Pegasus Laboratories, Inc.

Pegasus Laboratories, Inc. is a full-service Contract Development and Manufacturing Organization, or CDMO, with a very special purpose: improving the lives of animals. Through our leading veterinary brand, PRN Pharmacal, we create trusted veterinary products that promote animal wellness, including behavior modification, urinary incontinence, and seizure management. Our team of professionals, including manufacturing, quality assurance, business development, scientists and chemists, regulatory experts, and veterinarians, offers the complete package, from idea through development and regulatory approval, to production and marketing.

Pegasus Labs, part of the PBI-Gordon Companies, Inc., is 100% employee-owned with more than 500 employee-owners, working together in pursuit of mutual success. We are growing – come join us!

The Computer Systems Quality Engineer position develops the necessary computer systems validation program encompassing all GMP processes. Manage and coordinate all affairs related to the approved validation program to assure compliance with all relevant regulations to include FDA 21 CFR Part 11, EU GMP Volume 4 Annex 11, GAMP, other relevant regulations, and company SOPs.

• Uses industry best practice and quality engineering principles to create and enforce a computer systems validation program as part of the overall informational technologies (IT) systems architecture. This includes, but is not limited to, all stages of product selection and business/manufacturing/quality software system implementation.
• Develop the PBI Enterprise IT software change management program, process, approval, and documentation; key area of focus will be compliance with regulatory requirements and supporting best practices in documentation of validated system change.
• Manage the change control process for computer systems.
• Develop, implement, and maintain approved Standard Operating Procedures for the validation of GMP computer systems.
• Write and execute necessary protocols for the continued validation of computer and software systems with impact to GMP.
• Ensure timely and effective completion of validation activities.
• Ensure the compliance of the activities of the IT department with respect to established computer system validation program.
• Provide audit support related to all validated computer systems during customer or regulatory agency audits.

Provide cGMP guidance and support to other departments related to computer system validation

Qualifications

• Education: BS/MS Degree (IT, Engineering/Chemistry preferred).
• Experience: Minimum of 5 years’ experience in the pharmaceutical, medical device, and/or biotechnology manufacturing industry with product software quality engineering and/or assurance experience.
• Specialized knowledge: Background in 21 CFR Part 11-compliant software validations and EU Volume 4 GMPs Annex 11 Computerized Systems, including systems such as inspection systems, vision systems, manufacturing execution systems, quality management systems, laboratory information management systems and enterprise resource planning (ERP) systems (Microsoft D365 experience preferred but not required).
• Special skills: Software and hardware validation experience. Change Management experience in a regulated environment. Knowledge of applicable industry standards, regulations, and requirements (e.g., GAMP, US, Canada, and EU pharmaceutical GMPs, Quality Systems Regulations 21 CFR part 11). Proficient with Microsoft SharePoint Online.

Pegasus Laboratories, Inc. is an equal opportunity employer.