Role Summary
Engineer - Automation Engineering – Laboratory and Analytical Equipment. Provide automation support for one or more operating areas across site and/or for capital projects. Support GMP operations, maintain compliant control applications and systems, and mentor staff within the process control organization.
Responsibilities
- Technical Leadership
- Mentor process control team, including design, controls philosophy, implementation and commissioning
- Process control work implementation and coordination
- Develop and implement the Automation Engineering Project Plan
- Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications
- Lead/participate in design reviews and DeltaV application, Laboratory and Analytical equipment application reviews, attend equipment and software FATs
- Lead a team of automation engineers supporting commissioning
- Provide periodic status updates to Project Management
- Devising functional requirements and process control strategies for control systems in collaboration with Process Engineering
- DCS software design, coding/configuration and testing (sequence logic, graphics, batch software, etc.)
- Automation engineering including design, tuning and troubleshooting of control loops
- Implementing and supporting electronic systems (such as plant historians) used to capture process automation related production data
- Maintain the validated state of the site control systems in line with quality standards including validation strategies and documentation
- Automation support for capital projects including new product introductions
- Promoting automation to improve productivity, operational efficiency and compliance
- Developing a network of corporate contacts and leveraging corporate expertise when needed
Qualifications
- Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling Laboratory and Analytical systems and equipment, and Systems Integration
- 8+ years working experience in Biopharma engineering, operations, or manufacturing
- Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI)
- Experience in commissioning, qualifying and supporting Analytical equipment such as cell counters, environmental testing, filter testing, etc.
- Experience in facilitating and driving decision-making at an organizational level
Skills
- Knowledge of GMP and regulatory requirements
- Computer system validation
- Strong problem-solving, planning, and organizational skills
- Effective written and verbal communication for technical and non-technical audiences