Job Description
Duties and Responsibilities
- Serve as primary point of contact and Subject Matter Expert for companies I&C and OT system(s)
- Identify, analyze, and design improvements to facility and equipment automation and control systems
- Explore implementation of new automation, controls, and instrumentation technologies
- Develop and maintain engineering documentation such as PFD’s, P&ID’s, design specifications, etc.
- Create and modify instrumentation and controls designs, support documentation, and procedures.
- Assist in conceptional design of server and network architecture
- Develop instrumentation, hardware, and automation plans and specifications
- Drive and manage FAT, SAT, commissioning, and installation qualification
- Support debug, operational and performance qualification, and handover to operations
- Provide automation engineering expertise to support site Good Manufacturing Practices (GMP’s) including investigations, CAPA’s, audits, inspections, permits, and other technical requests
- Provide OT, automation, controls, and instrumentation oversite as a member of the Engineering Master Specification Team
- Adheres to consistent and predictable in-person attendance
- Responsibilities may increase in scope to align with company initiatives
Required Skills and Abilities
- Strong working knowledge of instrumentation, automation concepts, controls design, programming (PLC’s), and interface development (HMI’s)
- Strong working knowledge of Rockwell software and all supporting modules (Rockwell FactoryTalk System, FT View, FT AssetCenter, FTLinx, FT Historian, etc.).
- Working knowledge of Aveeva PI development and configuration
- Working knowledge of SmartSights WIN 911 development and configuration
- Strong understanding and demonstrated ability with engineering principles and techniques
- Knowledge of FDA cGMP’s
- Proficiency in ISA standards and practices for instrumentation
- Excellent verbal and written communication skills
- Excellent organizational skills and attention to detail
- Communicates effectively and maintains productive relationships with clients and coworkers
- Excellent time management skills with a proven ability to meet deadlines
- Excellent analytical and problem-solving skills
- Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus
- Accepts feedback from a variety of sources and constructively manages conflict
- Ability to prioritize tasks and to delegate them when appropriate
- Ability to function well in a high-paced and at times stressful environment
- Proficient with Microsoft Office Suite or related software
Education and Experience
- Bachelor’s degree in engineering required; Electrical, Mechanical, or Chemical Engineering disciplines preferred
- Minimum of five (5) years of process instrumentation experience in an engineering role
- Preference of five (5) years of relevant GMP experience within the Pharmaceutical or Biotechnology industry
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
- Ability to walk between multiple facilities
- Must be able to access equipment that requires crouching, bending, reaching overhead and climbing a ladder
