Mid/Senior Level Validation Engineer

Job DescriptionJob Description

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.

Scope of Responsibility:

• Mid-Level/Senior Validation Engineer / Specialist for a new Drug Product Sterile Clinical Manufacturing facility.
• This project is expected to last for 3+ years, with needs being assessed annually.
• Position would support the commissioning and qualification of new aseptic fill finish and lyophilization equipment.

Essential Functions:

• Responsible for the development and execution of Validation Life Cycle deliverables associated with this project.
• As part of a team, this candidate will report to, and help the Project Manager execute the project from a C&Q perspective, creating and executing 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, Lyophilization, Autoclaves and EU Grade B, C and D Facilities.

Education & Experience:

• 5+years of C&Q experience including using ISPE C&Q Guidelines, with knowledge of Kneat e-Validation Software .
• Prior experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• The ability to work independently with minimal direction while writing and communicating clearly is crucial.

Travel:

• Project is expected to be mostly remote for the rest of 2025, with some trips to the site required for training, team meetings, etc. After that, site work is required.
• Possible travel required for FATs, Vendor Audits, etc.
• Travel costs will be reimbursed in accordance with Compli and project policies.
• However, local personnel .

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 in our workforce by including all individuals regardless of , , , , , , marital status, genetic information, , , expression, , veteran status, status, or any other status protected by law.