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.
Union Agener Animal Health, located in the city of Augusta, Georgia, United States, is a biotechnology unit dedicated to animal health.
The plant was acquired in October 2018 by Fernando de Castro Marques, a majority shareholder of União Química, one of the largest groups in the pharmaceutical industry in Brazil. “Now we are in full control of operations and we will begin production of new Posilac® batches to fully satisfy the demands of the American market and other export markets,” says Fernando de Castro Marques, president of Union Agener and Grupo União Química Farmacêutica.
The unit has state-of-the-art technology and produces, on a large scale, Posilac® product (rbST – recombinant bovine somatotropin), used to increase milk production. The plant has 129,000 m² of total area, of which 24,000 m² is built, with a high-tech vertical production. The product is marketed globally under the trademarks Posilac® and Lactotropin.
This factory complex is FDA certified, having the product present in 22 countries, including the USA.
