Mid/Senior Level Validation Engineer

ZipRecruiter; Philadelphia (Philadelphia County); Remote; USD 85,000 - 110,000; Full time

Job summary

A leading company in the Life Sciences industry is seeking a Mid-Level/Senior Validation Engineer for a new Sterile Clinical Manufacturing facility. The role involves supporting the commissioning and qualification of aseptic fill-finish and lyophilization equipment, ensuring project deliverables are met. This position offers mostly remote work until 2025, with site visits for training and meetings thereafter.

Qualifications

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

Responsibilities

• Develop and execute Validation Life Cycle deliverables.
• Collaborate with the team to ensure timely completion of validation deliverables.

Skills

Communication

Problem Solving

Education

C&Q experience using ISPE C&Q Guidelines

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 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 enabled Compli, LLC to become part of an integrated network of services, providing 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 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 team and report to the Project Manager to execute the project from a C&Q perspective, ensuring timely completion of validation deliverables aligned with the project schedule.
• 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.

Travel:

• Mostly remote work for the rest of 2025, with some site visits for training and meetings. Post-2025, site work will be required.
• Possible travel for FATs, Vendor Audits, etc., with travel costs reimbursed per company policies.

At Compli, we value innovative and intelligent individuals 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.

We are an Equal Employment Opportunity Employer, promoting diversity and inclusion regardless of race, religion, marital status, genetic information, gender identity, veteran status, or any other protected status by law.