Automation Specialist

• In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance.
• Such accommodation may not pose an undue hardship to client, its operations, or its staff.
• This position provides an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.
• Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
• Complete complex or novel assignments.
• Support non-standard shift organization including extended hours.
• Development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.
• Prompt and regular attendance to workplace.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
• Develop technical solutions to complex problems using the ingenuity and creativity.
• Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems , Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
• Develop of detailed specification, engineering documents, SOP and operating standards.
• Interacts effectively with variety of communication and working styles. 20. Management of contractors and vendors.
• Troubleshoot and resolve equipment, automation or process issues in the field.
• Working closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
• Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
• Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.

Education Requirements: 

• Doctorate degree OR Master degree in Engineering and 3 years of experience in the Pharmaceutical or Biotechnology industries
• OR Bachelor degree in Engineering and 5 years of experience in the Pharmaceutical or Biotechnology industries
• Electrical Engineer or Mechanical Engineer preferred

• Experience troubleshooting PLC based systems, control panels.
• Knowledge in RS Logix, programming.
• 5+ years of engineering experience in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
• Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services.
• Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
• Experience with Tech Transfer, Process Design, Commissioning, validation and change control methodology.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
• Excellent written and verbal communication skills and the ability to work with minimum direction.
• Interpersonal and facilitation skills and ability to work in a collaborative team based environment.
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
• Ability to lead and influence cross-functional teams and embrace a team-based culture.
• In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs:
  • Rockwell Automation Factory Talk & ControlLogix PLC Platform.
  • Rockwell PLC5/SLC500 PLC families Controllers.
  • Rockwell Automation RSView SE and FTBatch systems.
  • DeviceNet technologies.
• Strong knowledge in programing language (e.g. VBA)
• Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure preferred. 
• Understanding of Operational Excellence and Lean transformation in the automation and engineering Context.
• Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
• Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage.
• Work schedule flexibility to support 24/7 operations and after-hours engineering coverage.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• ISA Certified Automation Professional.
• Familiarity with validation processes and documentation in a highly regulated environment.
• Ability to interpret and apply GMPs in addition the application of engineering science to production.
• Able to develop solutions to routine technical problems of limited scope.
• Comprehensive understanding of validation protocol execution and knowledge of validation processes as applied to new equipment installations.