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
Responsibilities: - - - - - - - - -The Validation Engineer leads
validation efforts associated with the operation of the site.
Primary areas of focus includes equipment qualification,
commissioning activities, projects. - - - - - - - - -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 reports. - - - - - - - - -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 operations.
- 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.
- Minimum of three years Pharmaceutical/Biomedical/Biotechnology
- Two years previous process, equipment and facility validation
Special Skills: - - - - - - - - -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 areas:
- 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: - - - - - - - - -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
Keywords: Union Agener, Inc., Augusta , Validation Engineer, Engineering , Augusta, Georgia
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