17 days old

Validation Enigneer

Kelly Engineering Resources
Wilmington, NC 28401
  • Job Code
Validation Engineer

Permanent position

Charleston, SC



The Validations Engineer is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation activities.  Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, cleaning and process validation projects; conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; monitoring compliance; developing documentations as required for projects; and consulting on validation and cGMP questions and issues.  The position requires superior leadership behaviors of the core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.


Job Duties

•             Performs the qualification and validation of equipment and systems.

•             Assists in equipment selection and specification.

•             Works on problems of moderate scope in which analysis of situation or data requires a review of

               identifiable factors.

•             Exercises judgment within defined procedures and practices to determine appropriate action.

Maintains all documentation pertaining to qualification and validation.
Develops procedures and/or protocols.
Serves as information resource for validation technicians, contractors and vendors.
Executes procedures and/or protocols.
Composes/revises SOP’s and master validation plans.
Supports facility, utility, instruments and equipment.

•             Ensures timely completion and compliance with cGMP and all other relevant company training  



 Job Requirements

•             Bachelor’s Degree with 2-4 years of related experience.

 •            Consistently demonstrates honesty and integrity through personal example.

•             Follows all safety policies and leads by example a safety first culture.

•             Produces high quality work product with a focus on first time right.

•             Complies with the company code of conduct and policies and regulatory standards.

 •            Good knowledge of quality assurance reviews of validations documentation.

•             cGMP training and basic understanding.

•             Good knowledge of pharmaceutical GMP environment.

•             Basic knowledge of Kaye Validator 2000.

•             Good understanding of and ability to utilize Pro Cal.

•             Strong communication skills (oral and written).

•             Strong mechanical skills.

•             Strong working knowledge of Microsoft Office applications.

•             Positive team player.

Experience validating a broad range of equipment such as:

•             Qualification/Requalification of Steam Sterilizers, Terminal Sterilization Cycles, Lyophilizers,   

               Depyrogenantion Ovens, Chambers/Incubators, Tanks/Vessels/Mixers.

•             Commissioning of Non-GMP equipment, instruments, and facilities.

•             Validating GMP processes and critical equipment.

•             Temperature Mapping via Kaye software (Kaye Valprobes and Kaye Thermalcouples).

•             Documentation and technical writing skills required for protocols, deviations, risk assessments,

               and audit responses.

•             Required to participate in regulatory and client audits.

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

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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]


Posted: 2020-02-08 Expires: 2020-03-09

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Validation Enigneer

Kelly Engineering Resources
Wilmington, NC 28401

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