Mid/Senior Level Validation Engineer

Compli; Hershey (PA); Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a Mid-Level/Senior Validation Engineer for a cutting-edge Drug Product Sterile Clinical Manufacturing project. This role involves developing and executing Validation Life Cycle deliverables while collaborating with a dynamic team. With a focus on technical excellence, the company is transforming the industry through technology integration. Ideal candidates will have significant experience in commissioning and qualification, particularly with Aseptic Fill Finish Equipment. If you are a problem-solver looking to make a meaningful impact, this opportunity is for you.

Qualifications

• 5+ years in C&Q, with knowledge of ISPE guidelines.
• Experience with Aseptic Fill Finish Equipment is essential.

Responsibilities

• Develop and execute Validation Life Cycle deliverables.
• Collaborate with team and ensure validation activities meet schedules.

Skills

Commissioning and Qualification (C&Q)

ISPE C&Q Guidelines

Clear Communication Skills

Education

Bachelor's Degree in Engineering or related field

5+ years of relevant experience

Tools

Kneat e-Validation Software

Job description

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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 wide range of services to help companies meet and exceed their goals. Understanding regulations and quality assurance activities related to operations, vendors, engineering, construction, and contractors is crucial in today’s environment. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating a broad 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.
• This project is expected to last over 3 years, with annual assessments.
• 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 team and report to the Project Manager, ensuring validation activities meet schedule requirements.
• Work with equipment and systems including Sterile Fill/Finish manufacturing, Lyophilization, Autoclaves, and EU Grade B, C, and D Facilities.

Education & Experience:

• At least 5 years of C&Q experience, familiar 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 with clear communication skills is essential.

Travel:

• The project is primarily remote in 2025, with some site visits for training and meetings; site work will be required afterward.
• Potential travel for FATs, Vendor Audits, etc., with expenses reimbursed per company policies.

It’s more than just a job…

At Compli, we value innovative and intelligent problem-solvers. We are known for technical excellence and strive to create solutions that improve quality of life. We are transforming the industry through technology integration in design and construction.

We are an Equal Employment Opportunity Employer committed to diversity and inclusion, welcoming all individuals regardless of age, race, religion, gender, sexual orientation, gender identity, disability, veteran status, or other protected classes.