Mid/Senior Level Validation Engineer

GBA Companies; Marietta (PA); Hybrid; USD 70,000 - 110,000; Full time

Job summary

An innovative company in the life sciences sector seeks a Mid-Level/Senior Validation Engineer to support the commissioning and qualification of a new Drug Product Sterile Clinical Manufacturing facility. This role offers the opportunity to work primarily remotely through 2025, with on-site responsibilities thereafter. You will collaborate with a dedicated project team to ensure validation activities meet project schedules. We value intelligent problem solvers committed to technical excellence and creating remarkable solutions that enhance quality of life. Join us to make a significant impact in the industry!

Qualifications

• 5+ years of experience in Commissioning & Qualification.
• Familiarity with ISPE C&Q Guidelines is essential.

Responsibilities

• Develop and execute Validation Life Cycle deliverables.
• Collaborate with project teams to ensure timely validation activities.

Skills

Commissioning & Qualification

Aseptic Fill Finish Equipment

Lyophilization

ISPE C&Q Guidelines

Kneat e-Validation Software

Effective Communication

Education

Bachelor's Degree in Engineering or Related Field

Tools

Kneat e-Validation Software

Job description

Current job opportunities are posted here as they become available.

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 wide range of services to help clients exceed their goals and objectives. Understanding regulations and quality assurance activities related to operations, vendors, engineering, construction, and contractors is crucial in today’s industry. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating a broader suite of in-house services for clients.

Scope of Responsibility:

• Mid-Level/Senior Validation Engineer / Specialist for a new Drug Product Sterile Clinical Manufacturing facility.
• The project is expected to last over 3 years, with annual assessments of needs.
• Support commissioning and qualification of aseptic fill finish and lyophilization equipment.

Essential Functions:

• Develop and execute Validation Life Cycle deliverables for this project.
• Collaborate with the project team and report to the Project Manager, ensuring validation activities are completed on time and meet project schedules.
• Work with equipment and systems including Sterile Fill/Finish manufacturing, Lyophilization, Autoclaves, and EU Grade B, C, and D Facilities.

Education & Experience:

• 5+ years of C&Q experience, including familiarity with ISPE C&Q Guidelines; experience with Kneat e-Validation Software is preferred.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently, communicate clearly, and write effectively.

Travel:

• Primarily remote work through 2025, with site visits for training and meetings; on-site work thereafter.
• Potential travel for FATs, Vendor Audits, etc., with travel costs reimbursed per company policies.

It’s more than just a job…

At Compli, we value innovative, intelligent people committed to solving problems. We are known for technical excellence and strive to create remarkable solutions for a higher quality of life, integrating new technology into industry practices.

Compli is an Equal Employment Opportunity Employer that promotes diversity and inclusion regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity or expression, disability, veteran status, pregnancy, or any other protected status.