Mid/Senior Level Validation Engineer

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

Job summary

An innovative firm is seeking a Mid-Level/Senior Validation Engineer to support a new Drug Product Sterile Clinical Manufacturing facility. This role involves developing and executing validation lifecycle deliverables while collaborating with a dedicated team. The position offers mostly remote work through 2025, with site visits required for training and meetings. Ideal candidates will have over five years of C&Q experience, particularly with aseptic fill-finish and lyophilization equipment. Join a company known for its technical excellence and commitment to creating remarkable solutions in the life sciences industry.

Qualifications

• 5+ years of C&Q experience in the pharmaceutical industry.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers.

Responsibilities

• Develop and execute Validation Lifecycle deliverables for the project.
• Collaborate with the team to ensure timely validation activities.

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

Tools

Validation Lifecycle Deliverables

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 them exceed their goals and objectives. In today’s environment, understanding regulations and quality assurance activities related to operations, vendors, engineering, construction, and contractors is crucial. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating more service options 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 needs assessments.
• Support commissioning and qualification of aseptic fill-finish and lyophilization equipment.

Essential Functions:

• Develop and execute Validation Lifecycle deliverables for this project.
• Collaborate with the team and report to the Project Manager to execute validation activities, ensuring timely completion aligned with project schedules.
• Work 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; knowledge of Kneat e-Validation Software is a plus.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently with minimal supervision and communicate clearly.

Travel:

• Mostly remote work through 2025, with some site visits for training and meetings; site work 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 talented individuals dedicated to solving problems. We are known for technical excellence and aim to create remarkable solutions for a higher quality of life, integrating new technology into industry practices.

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