Mid/Senior Level Validation Engineer

GBA Companies; Baltimore (MD); Hybrid; USD 80,000 - 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. In this role, you will develop and execute validation life cycle deliverables, ensuring compliance with industry standards. The position offers mostly remote work with some site visits, providing a unique opportunity to work on cutting-edge projects in the life sciences sector. Join a forward-thinking company that values innovative problem-solvers and strives for technical excellence in creating remarkable solutions that enhance quality of life.

Qualifications

• 5+ years of C&Q experience, familiar with ISPE C&Q Guidelines.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers is required.

Responsibilities

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

Skills

Commissioning and Qualification (C&Q)

Aseptic Fill Finish Equipment

Lyophilization

Clear Communication Skills

Education

Bachelor's Degree in Engineering or related field

5+ years of relevant experience

Tools

Kneat e-Validation Software

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 vast array of services that assist companies in exceeding their goals and objectives. Understanding regulations and quality assurance activities related to operations, vendors, engineering, construction, and contractors has become increasingly important.

In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating a broader suite of in-house services for our 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 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 deliverables meet project timelines.
• Work with equipment including Sterile Fill/Finish, Lyophilization, Autoclaves, and EU Grade B, C, 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 with clear communication skills.

Travel:

• Mostly remote work for 2025 with some site visits for training and meetings; site work expected 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 intelligent problem-solvers. We are known for technical excellence and strive to create remarkable solutions for a higher quality of life, integrating new technology into industry practices.

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