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Validation Engineer

Kelly Services

West Chester, PA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Validation Engineer

Jobid US41T8TK_BH1427251

Location: West Chester, PA, 19381, USA

Description **Validation Engineer**


The Validation Engineer will be responsible to coordinate and execute the Process Validations, IQ, OQ, PQ qualifications and Commissioning plans for clients Biologics R&D group located at West Chester, PA. The selected individual will be a key member of the R&D organization that owns and operates several cGxP laboratories and a brand new state-of-the art manufacturing facility located at the West Chester campus. The Validation Engineer will also be required to contribute to the development of Validation Master Plans, cleaning validation master plans and computer validation master plans.


The role is responsible for assisting in the timely development, execution and approval of all validation programs and documentation i.e. validation lifecycle documentation and quality records (e.g., SOPs, Change Controls, CAPAs, Deviations, etc.), ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices. This role will organize all validation activities to ensure completion of projects per schedule requirements. The Validation Engineer must have thorough knowledge of global regulatory requirements for validation, including ERES (Part 11 and Annex 11) and current GAMP5 guidelines.

The incumbent will be skilled in IT infrastructure qualification, manufacturing and laboratory equipment qualification, and GCP, GLP and cGMP regulatory procedures.

The position will be based in West Chester, PA. Occasional travel to other global client sites may be required.


Support all aspects of the Validation Life Cycle from design through operation and improvement as required for all TBU validation functions.

Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews.

Coordinate and execute approved process validation, IQ, OQ and PQ protocols for a new TBU production facility, and GMP/GLP laboratories supporting large molecule testing

Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing

Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data

Ensure validation testing performed by vendors is complete and accurate, work with vendors for issue resolution and validation deviation reporting.

Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation).

Support the revalidation program.

Ensure site alignment with corporate standards and cGMP guidelines.

Upkeep of validation standard operating procedures. Authoring and revising procedures within the electronic documentation management system.

Attends regular/recurring meetings to support the production facility during campaigns.

Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements. Independently contributes to development of new site validation standards.

Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives at TBU.

Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions.

Provides weekly and/or monthly project status reports to Management

Represent TBU in regulatory agency inspections as required.

Support continuous improvement projects and activities.

Regular reporting to QA and Manufacturing Management via updates and presentations.

Attend design meetings, and factory acceptance tests at vendor sites.

Attends meetings to provide validation input for new projects, and attends critical utility/environmental monitoring excursion team meetings.

Ensures training is up to date, provides training for validation contractors.



+ BS or equivalent combination of education and experience in life science or engineering; knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines)
+ Minimum 3 years of Equipment and/or Process Validation experience or combination of Validation and Engineering/Commissioning experience in the pharmaceutical industry required; preferably in biopharmaceutical products
+ Experience of successful interfacing with Facilities, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation
+ Understanding of utility systems, process instrumentation, automation systems, and analytical equipment
+ Experience of establishing overarching, comprehensive and compliant life-cycle programs for validation of process equipment, automation and utilities
+ Able to review Algebraic, Geometric and Statistical calculations for data analysis
+ Excellent oral and written communication skills

+ 5 or more years of related pharmaceutical Validation and Engineering/Commissioning experience
+ Validation experience with production equipment, support equipment, utilities, analytical lab equipment, computerized systems/automation, SIP/CIP, and cleaning verification
+ Cooperative, independent, critical thinking, multi-tasking and detail oriented
**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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