Mid/Senior Level Validation Engineer

GBA Companies; Philadelphia (Philadelphia County); Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Mid-Level/Senior Validation Engineer to support a new Drug Product Sterile Clinical Manufacturing facility. This exciting role involves developing and executing validation deliverables, collaborating with project teams, and working with advanced aseptic fill/finish equipment. With a focus on innovation and technical excellence, this company is dedicated to improving quality of life through pioneering industry changes. Remote work is expected through 2025, providing flexibility while contributing to a project that is set to last over three years.

Qualifications

• 5+ years of C&Q experience in the Life Sciences industry.
• Familiarity with ISPE C&Q Guidelines and validation software.

Responsibilities

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

Skills

Commissioning & Qualification (C&Q)

Aseptic Fill Finish Equipment

Lyophilization

ISPE C&Q Guidelines

Kneat e-Validation Software

Education

Bachelor's Degree in Engineering or related field

5+ years of experience in Validation

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 that 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 industry. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., enhancing our service offerings through an integrated network.

Scope of Responsibility:

• Mid-Level/Senior Validation Engineer / Specialist for a new Drug Product Sterile Clinical Manufacturing facility.
• This project is expected to last 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 team and report to the Project Manager to ensure validation activities 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, familiar with ISPE C&Q Guidelines; knowledge of Kneat e-Validation Software is a plus.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently, communicate clearly, and write effectively.

Travel:

• Remote work expected through 2025 with some site visits for training and meetings; onsite work thereafter.
• Potential travel for FATs, Vendor Audits, etc., with reimbursement per company policies.

It’s more than just a job…

At Compli, we value innovative, skilled people dedicated to solving problems. We are known for technical excellence and strive to create solutions that improve quality of life. We are pioneering industry change through technology integration.

We are an Equal Employment Opportunity Employer, promoting diversity and inclusion regardless of age, race, religion, gender, sexual orientation, disability, veteran status, or other protected categories.