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GMP Biotech Validation Specialist – Hybrid

  • Permanent
  • Anywhere

Website Pace Analytical Services, LLC

Pace Analytical Services, LLC

Company : Pace Analytical Services, LLC

Country: United States

Location : Frederick, Maryland

Post: Wed, 01 Feb 2023 20:37:48 GMT

Expires: Wed, 01 Mar 2023 23:59:59 GMT

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—————————— Job Description ——————————

OVERVIEW:

This individual will support the validation functions on client projects. Apply expertise cross functionally when required and demonstrates transferrable knowledge of validation concepts.

Note: This is an evergreen posting for future positions within our team. If you would like to be considered during the next round of hirings and have the qualifications, please apply.

RESPONSIBILITIES:
Generates and executes installation qualification, operational qualification, performance qualification, cleaning validation, and process validation protocols for support of GMP operations
Reviews equipment documentation, P&IDs, supplier documentation and as-built drawings
Analyzes validation data, generates Deviation/Investigation Reports and recommending resolutions
Generates validation summary reports
Generates equipment SOPs
QUALIFICATIONS:
Experience related to pharmaceutical, biotech or device manufacturing facilities including commissioning, factory acceptance testing, site acceptance testing, and validation
Relies on extensive experience and judgement to plan and accomplish tasks and goals
Detail orientated with excellent written and oral communication skills
Ability to work independently to solve problems
Motivated, efficient, self-starter skilled in time management

IND2

OFCCP Statement: Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.

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