Mid/Senior Level Validation Engineer

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

Job summary

An established industry player is seeking a Mid-Level/Senior Validation Engineer to join their team in a new Drug Product Sterile Clinical Manufacturing facility. This role involves developing and executing validation lifecycle deliverables, ensuring project timelines are met, and working with advanced manufacturing equipment. With a focus on innovation and technical excellence, this opportunity promises to challenge and enhance your skills. Enjoy the flexibility of primarily remote work through 2025, with a commitment to quality and a collaborative environment that values diversity and inclusion.

Qualifications

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

Responsibilities

• Develop and execute Validation Lifecycle deliverables.
• Support commissioning and qualification of aseptic fill-finish equipment.

Skills

Commissioning & Qualification

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

Kneat e-Validation Software

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 wide range of services to help companies exceed their goals and objectives. In today’s environment, 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 more services and 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 assessments of needs.
• Support commissioning and qualification of aseptic fill-finish and lyophilization equipment.

Essential Functions:

• Develop and execute Validation Lifecycle deliverables for this project.
• Assist the Project Manager in executing the validation lifecycle, ensuring timely completion aligned with project schedule.
• Work with equipment and systems including sterile fill/finish manufacturing, lyophilization, autoclaves, and EU Grade B, C, D facilities.

Education & Experience:

• 5+ years of Commissioning & Qualification 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, communicate clearly, and write effectively.

Travel:

• Primarily remote work through 2025, with site visits for training and meetings; onsite work thereafter.
• Possible travel for FATs, vendor audits, etc., with costs reimbursed per company policies.
• Preference for local candidates.

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

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 classes.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Design Services