Mid/Senior Level Validation Engineer

Compli; Marietta (PA); Hybrid; USD 70,000 - 110,000; Full time

Job summary

An innovative company is seeking a Mid-Level/Senior Validation Engineer/Specialist for a new sterile clinical manufacturing facility. This role will involve supporting the commissioning and qualification of aseptic fill finish and lyophilization equipment. The position offers a unique opportunity to contribute to a project expected to last over three years, with a focus on developing and executing validation deliverables while collaborating closely with the project team. If you are a problem-solver dedicated to advancing the industry through technology integration, this is the perfect opportunity for you.

Qualifications

• 5+ years of experience in Commissioning and Qualification.
• Familiarity with ISPE C&Q Guidelines and Kneat e-Validation Software.

Responsibilities

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

Skills

Commissioning and Qualification (C&Q)

Aseptic Fill Finish Equipment

Lyophilization

Kneat e-Validation Software

Communication Skills

Job description

Current Job Opportunity

We are seeking a Mid-Level/Senior Validation Engineer / Specialist for a new Drug Product Sterile Clinical Manufacturing facility. This project is expected to last for over 3 years, with annual assessments of needs. The role involves supporting the commissioning and qualification of aseptic fill finish and lyophilization equipment.

Responsibilities

• Develop and execute Validation Life Cycle deliverables for the project.
• Collaborate with the project team and report to the Project Manager to ensure timely completion of validation activities, supporting the overall project schedule.
• Work with equipment and systems including Sterile Fill/Finish manufacturing equipment, Lyophilization, Autoclaves, and EU Grade B, C, and D Facilities.

Qualifications

• At least 5+ years of C&Q experience, familiar with ISPE C&Q Guidelines; knowledge of Kneat e-Validation Software is preferred.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently with minimal supervision and communicate clearly.

Travel

• Initially remote work with some site visits for training and meetings, transitioning to full site work later.
• Potential travel for FATs, Vendor Audits, etc., with expenses reimbursed per company policies.

At Compli, we value innovative and intelligent individuals committed to solving problems. We are dedicated to creating remarkable solutions and advancing the industry through technology integration. We are an Equal Employment Opportunity Employer, promoting diversity and inclusion in our workforce.