Sr Controls Systems Engineer - DeltaV

• Support ongoing operations through technical assistance as it relates to the manufacturing and process automation systems.
• Provide a technical resource to operations customers to ensure that instrumentation and automation systems are designed and operating to meet production needs.

• Planning and execution of plant projects involving complex equipment changes and significant process improvements.
• Controls lead for tech transfers.
• Support resolution of equipment breakdowns and quality issues in the suites.
• Provide SME support to Manufacturing and other departments for the design and operation of process automation equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and processes automation systems including PI data analyses, review/troubleshooting code, etc. both during normal business hours and as part of an on-call rotation.
• Performs all work safely and meets the requisite training requirements.
• Participates in IPT/JPT in addition to other meetings as the Controls representative. Participates in audits and inspections as Controls SME if required.
• Owns and executes completion of CAPA actions.
• Initiates change controls and participates in all aspects of the change controls process. Review SOPs, Functional Specifications, and work instructions.
• Remain up to date on all assigned training activities.
• Perform other duties as assigned.

• Pharma/Biotech (or equivalent industrial automation). Supervisory/Project management experience preferred.
• Advanced - 5-10 years.
• Takes personal responsibility for promoting change in his/her area and helps others learn from experience to develop themselves.
• Business Acumen:
  Uses knowledge of his/her own business area and related areas to identify and develop operational/financial improvements.
• Collaboration:
  
  Works in partnership as an active member of his/her team and cross-functional working groups while also sharing information and knowledge across teams and functions.
• Customer Focus:
  Manages internal and external customer relations professionally and effectively while developing insights that can be used to enhance customer satisfaction or other metrics.
• Driving Results:
  Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time. Also secures buy-in from key stakeholders for projects and process improvements when required.
• Creates a positive work environment for his/her team and demonstrates high integrity. Takes personal accountability for defining and implementing his/her own development and supports others to do the same.
• May be required to provide direction to 1-2 Contractors working on projects within the group.
• May be responsible for monitoring timelines and established budgets to ensure that project deliverables are met on time and that the budget is not exceeded.
• Adherence to cGMPs is required at all times during the manufacture of APIs.
• All personnel own the quality of what they deliver and are responsible for notifying the applicable management member in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.
• Must comply with safety policies of the company and site. Works safely in cooperation with other departments when troubleshooting manufacturing issues and is aware of dangers and potential kinetic energy sources.

• Proficient with Microsoft Office Suite with focus on Outlook, Word, and Excel.
• Ability to think critically and logically.

• Automation Engineering
• Automation Systems
• Biopharmaceutical Manufacturing
• GMP Compliance
• GMP Documentation

• PLC Logic
• PLC Programming
• PLC Troubleshooting

• Bachelor’s of Science: applicable engineering field or Computer Science.

The hiring range for this position is $110 to $121.21/per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.