Mid/Senior Level Validation Engineer

ZipRecruiter; Marietta (GA); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in the Life Sciences industry is seeking a Mid-Level/Senior Validation Engineer for a new Drug Product Sterile Clinical Manufacturing facility. This role involves developing validation deliverables and collaborating with project teams to ensure timely completion. The position is mostly remote for 2025, with on-site work required thereafter.

Qualifications

• 5+ years of C&Q experience using ISPE C&Q Guidelines.
• Prior experience with Aseptic Fill Finish Equipment or Lyophilizers.

Responsibilities

• Develop and execute Validation Life Cycle deliverables.
• Collaborate with the project team to meet project schedules.

Skills

C&Q experience

Communication

Education

5+ years of experience

Tools

Kneat e-Validation Software

Job description

Job 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 in exceeding their goals and objectives. In today’s world, it’s more important than ever to understand regulations and quality assurance activities related to operations, vendors, engineering, construction, and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating a network of services that provides clients with more options to engage a comprehensive 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.
• Support the commissioning and qualification of new aseptic fill finish and lyophilization equipment.

Essential Functions:

• Develop and execute Validation Life Cycle deliverables for this project.
• Collaborate with the project team, report to, and assist the Project Manager in executing the validation from a C&Q perspective, ensuring timely completion of deliverables to meet project schedules.
• Work with equipment and systems including Sterile Fill/Finish manufacturing equipment, Lyophilization, Autoclaves, and EU Grade B, C, and D Facilities.

Education & Experience:

• 5+ years of C&Q experience using ISPE C&Q Guidelines, with knowledge of Kneat e-Validation Software.
• Prior experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently with minimal supervision and communicate clearly is essential.

Travel:

• The project will be mostly remote for the remainder of 2025, with some site visits for training and meetings. Post-2025, on-site work will be required.
• Possible travel for FATs, Vendor Audits, etc., with costs reimbursed per company policies.
• Local personnel may be involved as needed.

It’s more than just a job…

At Compli, we value innovative and intelligent people who want to solve problems. We are known for technical excellence and strive to create remarkable solutions for a higher quality of life. We are transforming the industry by integrating design and construction with new technology.

Compli is an Equal Employment Opportunity Employer, promoting diversity and inclusion regardless of race, color, religion, sex, sexual orientation, gender identity, marital status, genetic information, age, veteran status, or any other protected status by law.