Engineer - Process Automation / IDAP Site Expansion - Assembly

About the role

The Engineer – Process Automation will be a part of the IDAP Expansion Team, a dedicated team responsible for executing strategies and objectives to ensure successful delivery and ramp up of multiple assets within IDAP.

Responsibilities

• Ensure a safe working environment by enforcing and following HSE policies and ergonomic environment within process team.
• Participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.
• Wear proper personal protective equipment (gloves, steel-toed shoes, safety glasses) as required by local procedures and the activity being performed.
• Understand safe operation of the equipment within the area.
• Obtain technical expertise of equipment and processes in area of responsibility.
• Have a basic understanding of Infrastructure / Telecom.
• Knowledgeable in multiple technologies such as Vision, PLC, VFDs, etc.
• Knowledgeable in Data Integrity requirements and expectations, ensuring appropriate integration into assets within scope.
• Develop a deep understanding of Global and local requirements and expectations for Asset delivery.
• Understand equipment flow chart / process flow document, critical process parameters, and Control Strategy for responsible process area.
• Understand design and user requirements of equipment and fundamental understanding of the operational area’s processes where the asset will reside.
• Understand customer needs and issues associated with new and existing process control systems.
• Participate in project meetings, connect with delivery organizations and OEM and engage in the overall C&Q process throughout project, preparing asset for PV.
• Perform activities in accordance with cGMPs and applicable procedures.
• Proactively evaluate automation code to identify and correct code opportunities.
• Monitor, analyze, and trend data to define action plans for data integrity, process efficiency, and commercialization continuous improvements.
• Maintain compliance with AQMS (Asset Qualification Monitoring Strategy), automation change strategy, and ensure compliance with all requirements, policies, and regulations.
• Lead or manage small projects or initiatives related to automation technologies.
• Continuously monitor and perform assessments in the assigned area of support to proactively identify opportunities and implement corrections to deliver results, drive productivity, and to be more agile and competitive.
• Initiate change controls to optimize the systems or processes, including business case, technical recommendations, and resources / cost estimates.
• Implement and/or support implementation of the change controls (complete all information, follow up approval signatures, close the document).
• Participate at a Process Team member as technical SME and train individuals as appropriate to assume process automation engineering responsibilities.

Qualifications

• Bachelor's Degree in Engineering.
• Experience supporting GMP production.
• Qualified applicants must be authorized to work in the United States on a full-time basis.

Skills

• Previous experience in the Pharmaceutical Industry.
• Previous experience in the delivery of GMP production assets.
• Computer System Validation experience is desirable.
• Strong interpersonal and communications skills to be able to work effectively in a team-based environment.
• Ability to work safely to ensure the safety of self and others.
• Basic understanding of Infrastructure / Telecom.

Benefits

• 8-hour days, after-hour support.
• Extended travel / stays may be required to support / learn from other site start-ups for similar equipment.
• Travel to US and OUS (4-12 weeks/yr) will be required for OEM interactions, FAT testing, and other project requirements.

Pay

The anticipated wage for this position is $66,000 - $171,600.

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).