Union Agener, Inc.
Join to apply for the
Validation Engineer
role at
Union Agener, Inc. 2 days ago Be among the first 25 applicants Join to apply for the
Validation Engineer
role at
Union Agener, Inc. Position Description, Functions, Duties and Tasks:
The Validation Engineer leads validation efforts associated with the operation of the site. Primary areas of focus includes equipment qualification, process & cleaning validation, commissioning activities, computer system validations and ad hoc projects as business needs.
Develop, write, review and execute validation protocols and reports, risk assessments, SOP’s, validation plan for individual projects, URS, commissioning and decomissioning documents, installation, operation and performance qualification protocols and reports.
Leads validation work arising from change controls, capital projects, shutdown and also ongoing revalidation programs as necessary to ensure appropriate document lifecycle. 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, quality control 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.
Experience:
Minimum Of Three Years Pharmaceutical/Biomedical/Biotechnology Manufacturing Experience
Two years previous process, equipment and facility validation experience.
Additional Preferences:
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: IQ, OQ and PQ URS, Commissioning Statistics
Working knowledge of cGMPs, product lifecycle and validation regulatory requirements/ guidelines understanding strongly desired.
Excellent technical writing skills.
Working knowledge of statistical process control tools (such as Six Sigma) desired.
Ability to participate in and execute risk based decisions.
Good interpersonal, verbal communication, writing skills.
Must be able to multitask, have initiative and set priorities.
What do we offer?
Competitive Salary
Competitive Benefits Package and Employee Assistance Program
401(k) Plan + Company Match
Vacation + End of Year Vacation (Company Sponsored)
Growth Opportunities to expand your career Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Biotechnology Referrals increase your chances of interviewing at Union Agener, Inc. by 2x Get notified about new Validation Engineer jobs in
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Validation Engineer
role at
Union Agener, Inc. 2 days ago Be among the first 25 applicants Join to apply for the
Validation Engineer
role at
Union Agener, Inc. Position Description, Functions, Duties and Tasks:
The Validation Engineer leads validation efforts associated with the operation of the site. Primary areas of focus includes equipment qualification, process & cleaning validation, commissioning activities, computer system validations and ad hoc projects as business needs.
Develop, write, review and execute validation protocols and reports, risk assessments, SOP’s, validation plan for individual projects, URS, commissioning and decomissioning documents, installation, operation and performance qualification protocols and reports.
Leads validation work arising from change controls, capital projects, shutdown and also ongoing revalidation programs as necessary to ensure appropriate document lifecycle. 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, quality control 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.
Experience:
Minimum Of Three Years Pharmaceutical/Biomedical/Biotechnology Manufacturing Experience
Two years previous process, equipment and facility validation experience.
Additional Preferences:
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: IQ, OQ and PQ URS, Commissioning Statistics
Working knowledge of cGMPs, product lifecycle and validation regulatory requirements/ guidelines understanding strongly desired.
Excellent technical writing skills.
Working knowledge of statistical process control tools (such as Six Sigma) desired.
Ability to participate in and execute risk based decisions.
Good interpersonal, verbal communication, writing skills.
Must be able to multitask, have initiative and set priorities.
What do we offer?
Competitive Salary
Competitive Benefits Package and Employee Assistance Program
401(k) Plan + Company Match
Vacation + End of Year Vacation (Company Sponsored)
Growth Opportunities to expand your career Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Biotechnology Referrals increase your chances of interviewing at Union Agener, Inc. by 2x Get notified about new Validation Engineer jobs in
Augusta, GA . Aiken, SC $90,985.00-$136,477.00 1 month ago Quality Engineer - Fluids and Technical Cleanliness
Quality Engineer - Fluids and Technical Cleanliness
Augusta, GA $110,000.00-$125,000.00 1 week ago Aiken, SC $77,692.00-$116,538.00 1 month ago Augusta, GA $80,000.00-$120,000.00 7 months ago Martinez, GA $87,800.00-$153,700.00 22 hours ago Augusta, GA $67,250.75-$97,250.75 1 month ago Experienced Software Quality Assurance Engineer
Augusta, GA $99,221.33-$134,221.33 10 months ago Augusta, GA $90,000.00-$135,000.00 1 day ago Experienced Engineer, Operational Technology
Aiken, SC $85,700.00-$180,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr