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NOTE: 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

Responsibilities:

• The Validation Engineer/Scientist leads validation efforts associated with the operation of the site. Primary areas of focus include cleaning validation, sterilization validation (steam, VHP), process validation, temperature monitoring (chambers, freezers, warehouses) and revalidation activities.
• Develop, write, review and execute validation protocols and reports, risk assessments, SOP’s, VMP and validation plan for individual projects.
• Leads validation work arising from change controls, capital projects, shutdown and ongoing revalidation programs. 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.

Qualification/Skills:

• 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 manufacturing experience
• Two years previous process, equipment and/or cleaning validation experience
• 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

Cleaning Validation

Autoclave and system Steam In Place (SIP) and Dry Heat Sterilization

Isolator (VHP) surface sterilization cycle development and validation

Process Validation

Temperature monitoring studies

Statistics

Additional Preferences:

• 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.