Mid/Senior Level Validation Engineer

Compli; Philadelphia (Philadelphia County); Hybrid; USD 75,000 - 110,000; Full time

Job summary

An established industry player in the Life Sciences sector is seeking a Mid-Level/Senior Validation Engineer for a new Drug Product Sterile Clinical Manufacturing facility. This role involves supporting the commissioning and qualification of aseptic fill finish and lyophilization equipment, ensuring all validation activities align with project schedules. The position offers the flexibility of mostly remote work for 2025, transitioning to onsite requirements thereafter. The company values innovative thinkers committed to technical excellence and improving quality of life through their work. If you have a passion for problem-solving and meet the qualifications, this could be the perfect opportunity for you.

Qualifications

• 5+ years of experience in Commissioning and Qualification.
• Familiarity with ISPE C&Q Guidelines and Aseptic Fill Finish Equipment.

Responsibilities

• Developing and executing Validation Lifecycle deliverables.
• Collaborating with the team to ensure timely validation activities.

Skills

Commissioning and Qualification (C&Q)

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

Autoclaves

Job description

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About Compli, LLC

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 exceed their goals and objectives. In today's world, understanding regulations and quality assurance activities related to operations, vendors, engineering, construction, and contractors is more important than ever. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating our services into a broader network to give clients more options for engagement.

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.
• The role involves supporting the commissioning and qualification of aseptic fill finish and lyophilization equipment.

Essential Functions

• Developing and executing Validation Lifecycle deliverables for this project.
• Collaborating with the team and reporting to the Project Manager to ensure validation activities are completed on time and aligned with the project schedule.
• Working with equipment and systems such as 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.
• Prior experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently with minimal supervision and communicate effectively.

Travel

• The project will be mostly remote for the rest of 2025, with some site visits for training and meetings. Post-2025, onsite work will be required.
• Potential travel for FATs, Vendor Audits, etc., with expenses reimbursed per company policies.

Our Culture

At Compli, we value innovative and intelligent individuals who want to solve problems. We are committed to technical excellence and creating solutions that improve quality of life. We are industry leaders in integrating design and construction with new technology.

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