Responsibilities

• Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
• Oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention.
• Prepare scopes of work and lead automation resources as required to complete work within the project timelines.
• Develop equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
• Take programs from concept through execution while managing all stages in the process utilizing a strong set of project management tools.
• Maintain procedures to meet GMP requirements, CFR’s, and internal company policies.
• Lead or contribute to programs supporting process commercialization of new products to ensure a smooth transition from development to GMP manufacturing.
• Participate in operational excellence and continuous improvement efforts.
• Partner with Quality to ensure a quality and compliant manufacturing environment.
• Solve technical issues impacting production.
• Support 24×7 site-based operations.
• Create and update procedures to drive operational efficiency and compliance.
• Implement and revise SOPs to conform to the highest industry standards and company policies.
• Deploy, maintain, and upgrade manufacturing applications.
• Perform investigations of non-conformances related to automation systems.
• Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.
• Execute change controls to update and upgrade automation systems and equipment.
• Other related duties as assigned.

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field, or related technical field, with 5 years’ work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 9 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• 5 years of experience in cell culture, recovery, purification, aseptic fill/finish.
• Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV).
• Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7).
• Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian).
• Experience in authoring and executing test protocols for automation system level commissioning and qualification.
• Proven experience applying S88 in an automated environment.
• Working knowledge of the field device signal wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
• Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
• Experience writing and executing change controls in change management systems.
• Able to develop MS SQL queries.
• Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Knowledge of Quality by Design, six-sigma, LEAN, and operational excellence tools in creating efficient and quality-driven processes and end products.
• Excellent oral and written communication skills.
• Strong project management skillset.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Experience providing technical support on manufacturing issues and able to drive toward issue resolution