Senior Validation Specialist/Validation Lead
GBA

Job Info

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Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.

We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today•s world, it•s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.

Job Description: Validation Lead for a new Drug Product Sterile Clinical Manufacturing facility. This project is expected to last for 3-4 years, with needs being assessed annually. Estimated Start date: January 2025.

Responsibilities:

• Responsible for the management of Validation Life Cycle deliverables associated with this project
• Help the Project Manager manage the project from a C&Q perspective, managing the validation life cycle deliverables while ensuring deliverables are completed on time to meet the overall project schedule.
• Equipment and Systems include Sterile Fill/Finish manufacturing equipment, Critical Utilities and EU Grade Facilities.

Qualifications: 10+ years of C&Q experience including PM experience using ISPE C&Q Guidelines, with knowledge of Kneat e-Validation Software preferred.

Travel: Possible travel required for FATs, Vendor Audits, etc. Travel costs would be reimbursed.

It•s more than just a job•

At Compli, we are about innovative and intelligent people who want to solve problems. We•re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.

At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

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