• BS/BA required, preferably in electrical or chemical engineering.
• Prior instrument engineering experience in the pharmaceutical industry for 5 or more years.
• Prior experience leading the design, programming, start-up, and troubleshooting of process control instrument including PLC systems.
• Prior experience in the design, programming, start-up, and troubleshooting of process control instrumentation including PLC and SCADA systems.
• Prior manufacturing or development process instrument engineering experience in the bulk biopharmaceutical industry.
• Familiarity with Good Manufacturing Practices and NIH guideline for large scale recombinant biological processing including secondary manufacturing such as sterilization, vial filling lines, lyophilizers and packaging equipment.
• Prior experience in a cGMP regulated industry including experience with relevant European regulatory requirements and 21 CFR part 11. Working knowledge and prior application development using PLC programming (AB Siemens), SCADA, HMI configuration (Intellution Fix32 and iFix, Wonderware.) strongly preferred.
• Familiarity with regulatory expectations regarding electronic records and electronic signatures.
• Ability to follow written procedures and document results in a neat and precise manner.
• Excellent computer skills.
GSK Vaccines in Hamilton is located in the heart of the Bitterroot Valley in western Montana, surrounded by some of the most spectacular scenery in the world. The site manufactures MPL® or Monophosphoryl Lipid A, a unique adjuvant that is used in a number of GSK vaccines. In addition, Hamilton has a small but dedicated research organization discovering, characterizing and developing additional novel adjuvant compounds to support the growth of the GSK vaccine portfolio.
The Automation Discipline Engineer participates in the technical aspects of process automation systems, low voltage systems, and PLC controls. Responsibilities include coordination of suppliers, commissioning, and IQ/OQ for new projects and upgrading/modifying existing systems. Since the automation control system is only a part of the facility, the Automation Discipline Engineer is required to coordinate efforts with other members of local and global teams.
Environment Health & Safety: The Automation Discipline Engineer ensures system compliance with GSK Bio-Hamilton safety and environmental guidelines.
Quality & Compliance: The Automation Discipline Engineer ensures system compliance with GSK Bio-Hamilton and cGMP requirements and specifications.
Continuous Improvement: The Automation Discipline Engineer seeks to improve system efficiency and effectiveness.
Accountability: The Automation Discipline Engineer is accountable to comply with GSK Bio-Hamilton SOP's, GSK Bio GSOP's, GSK policies, and regulatory requirements.
Key Responsibilities include the following:
Process automation programming, troubleshooting, and qualification.
Supports production in investigations and troubleshooting.
Authors qualification protocols as required.
Provide budgetary estimates for proposed automation systems and upgrades.
Establish plans for system execution and installation.
Interface with vendors and sub-contractors.
Performs triennial SOP reviews as required.
Performs gap analysis of local SOPs against GQPs and GQMPs.
Other tasks as assigned by supervisor.
You may apply for this position online by selecting the Apply now button.
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