Company: Union Agener, Inc.
Posted on: August 6, 2022
Job Description - Validation Engineer Supervisor Title:
-Validation Team Lead Position Type: Full timeLocation: Union
Agener, Inc. -- Augusta, GA 30901 -Position Description and
--- - - - - - - - -The Validation Engineer leads validation efforts
associated with the operation of the site. Primary areas of focus
includes equipment qualification, commissioning activities,
--- - - - - - - - -Develop, write, review and execute validation
protocols and reports, risk assessments, SOP's, -validation plan
for individual projects, URS, commissioning documents,
installation, operation and performance qualification protocols and
--- - - - - - - - -Leads validation work arising from change
controls, capital projects, shutdown and also ongoing revalidation
programs if necessary. Background in root cause analysis, OOS
investigations and CAPA.
--- - - - - - - - -Provide validation subject matter expertise to
multi-function teams, advises operations on validation matters, and
participate in regulatory audits as validation SME.
--- - - - - - - - -Analyze data generated during validation and
determine suitability and quality attributes.
--- - - - - - - - -Initiate, investigate and report on validation
discrepancies and deviations.
--- - - - - - - - -Train other personnel to assist in the execution
of validation activities; provide oversight during execution.
--- - - - - - - - -Coordinate validation execution with various
units including process engineers, validation specialist and
- Prepare/Review site quarterly and annual product quality review
using statistics methods.Minimum Qualification (education,
experience and/or training, required certifications):Education:
- BA/BS degree in Engineering (ME, EE, or Chem. E), related
physical science or equivalent work experience required.Experience:
- Minimum of three years Pharmaceutical/Biomedical/Biotechnology
- Two years previous process, equipment and facility validation
--- - - - - - - - -Ability to demonstrate flexibility to meet
business needs/priorities -
--- - - - - - - - -Strong computer skills are essential including
Word, Excel, and PowerPoint, Good interpersonal skills, teamwork,
planning, organization and prioritizing are essential.
--- - - - - - - - -Expertise strongly desired in the following
- OQ and PQ
- Working knowledge of cGMPs, product lifecycle and validation
regulatory requirements/ guidelines understanding strongly
- Excellent technical writing skills.
- Working knowledge of statistical process control tools (such as
Six Sigma) desired.
- Ability to participate in and execute risk based
- Good interpersonal, verbal communication, writing skills.
- Must be able to multitask, have initiative and set
--- - - - - - - - -Qualified candidates must be legally authorized
to be employed in the United States. Union Agener does not
anticipate providing sponsorship for employment visa status (e.g
H-1B or TN status) for this employment position
Keywords: Union Agener, Inc., Augusta , Validation Engineer, Engineering , Augusta, Georgia
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