Senior Automation Engineer

Serán is seeking a Senior Automation Engineer to manage automated manufacturing and process equipment needs, control systems, and support facility design and qualifications as part of the Seran’s expansion efforts.  This position will require a strong engineering background in qualified pharmaceutical/biotech industrial practices, preferably with specialized expertise in spray drying and solid dosage form applications and technology. Primary duties include design of automated equipment and machinery used to complete otherwise manual processes and tasks, evaluation and testing of existing automated systems, defining areas where introducing automation could improve production and efficiency, and providing technical support in relation to automated systems when necessary.

• 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  

• 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

• 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

• 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