Mid/Senior Level Validation Engineer

Compli; Baltimore (MD); Remote; 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. This role involves developing and executing validation life cycle deliverables, collaborating with project teams, and ensuring compliance with stringent industry standards. With a focus on innovation and technical excellence, this position offers the opportunity to contribute to transformative projects in the life sciences sector. Ideal candidates will have extensive experience in commissioning and qualification, particularly with aseptic fill finish and lyophilization equipment. Join a dynamic team dedicated to improving quality of life through cutting-edge solutions.

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 and report to the Project Manager.

Skills

Commissioning and Qualification (C&Q)

Aseptic Fill Finish Equipment

Lyophilization

Kneat e-Validation Software

Independent Work

Education

5+ years of relevant experience

Tools

ISPE C&Q Guidelines

Job description

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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 is crucial in today’s world. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating more 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 for 3+ years, with annual assessments.
• 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, ensuring validation activities meet project timelines.
• 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; Kneat e-Validation Software experience preferred.
• Experience with Aseptic Fill Finish Equipment or Lyophilizers is required.
• Ability to work independently and communicate clearly is essential.

Travel:

• Primarily remote work in 2025, with site visits for training and meetings; site work thereafter.
• Potential travel for FATs, Vendor Audits, etc., with costs reimbursed per company policies.

It’s more than just a job…

At Compli, we value innovative and intelligent individuals committed to solving problems. We are known for technical excellence and strive to create solutions that improve quality of life. We are transforming the industry through integrated design and technology.

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 statuses.