25 days old

Validation Engineer

Kelly Services
Gaithersburg, MD 20898
Validation Engineer (Gaithersburg, MD)

Client is in need of Validation Engineer, cGmp facility, to manage equipment qualification and validation and, calibration programs at Gaithersburg location. This position is a Direct Hire.

Your Tasks:

As a member of the team, you will have the opportunity to manage equipment qualification and validation and calibration programs at our Gaithersburg location. You will maintain and assure compliance with the Validation Master Plan, Calibration Program, regulatory requirements and site policies. Additionally you will be responsible for performing routine gap analysis for site Validation and Calibration Programs and correcting gaps as needed. The unique duties of this position will consist of drafting, authoring and executing validation protocols and supporting validation and technical assessments for quality. Furthermore, you will act as a subject matter expert in client and regulatory audits. Overall, your technical nature will champion the continued developments and growing success of products.

The Role:

Participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.

Coordinate multiple projects, documenting activities and summary report templates.

Interact in a client facing position to support customer product launches.

Establish new templates, validation strategies and policies.

Review facility changes and provide input on re-validation.

Assessing risks involved in processing steps and related to equipment, developing and/or reviewing validation requirements and design deliverables.

Partner with contract validation teams to support and monitor efforts.

Monitoring validation strategies, ensure polices are followed, conducting validation studies in accordance with batch records/protocols.

Identify exceptions associated with validation protocol execution.

Improve existing lab processes to increase lab throughput, train peers and lab technicians, and seek repeatability & reproducibility of test results.

Facilitate product failure investigations by gathering and communicating objective evidence to relevant teams, help identify root cause and recommend corrective actions.

Serve as an internal expert on test methods, industry standards, data analysis tools, and Design of Experiments (DOE), Measurement System Analysis (MSA).

Use strong communication and interpersonal skills to serve internal customers such as Product Engineering, System Engineering, Product Management, and Technical Service, and to collaborate with peers, both locally and globally.


B.S. degree in Engineering or a scientific discipline.

5 years experience working in validation in the pharmaceutical and/or biotech industry; or equivalent combination of education and experience.

2-3 years recent experience working directly or very closely to Manufacturing and Quality floor.

Experience in Validation or related discipline.

GMP experience required or other regulated industry.

Competent at risk mitigation analyses for function.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-11-08 Expires: 2021-12-09

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Validation Engineer

Kelly Services
Gaithersburg, MD 20898

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