Senior Specialist Manufacturing Automation Engineer

Location: West Point

Job Description Our company aspires to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our manufacturing division and be part of a team that ensures the highest quality of raw materials, intermediates, and finished products. We work with a “Safety First, Quality Always” mindset striving for continuous improvement.

The Senior Specialist Manufacturing Automation Engineer in the West Point Digital Manufacturing Operations organization will be responsible for the manufacturing and supporting utilities process automation systems in the Barrier Operations Formulation and Filling facility at the West Point, PA site.

Responsibilities Troubleshooting challenging equipment/automation issues and innovating to improve manufacturing performance

Maintaining the automation systems in compliance with cGMPs through the life cycle of the equipment (initial qualification through retirement)
Providing support as an automated systems Subject Matter Expert within an existing production team, including technical assistance in fulfilling the automation requirements for the team Supporting peers in areas of expertise to ensure success of the team Reviewing automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety

Developing and supporting corrective actions for investigations related to automation or IT systems

Using technical knowledge to assure the efficient operation of a variety of automated processing and information technology systems

Participating in audits and training programs

Providing on-floor support of manufacturing activities

Generating and implementing change controls to meet the needs of the facility

Qualifications Required Bachelor  of Science (BS) in Engineering, Computer Science or related field

Minimum of five (5) years of experience in a manufacturing automation-related role in a regulated industry

Demonstrated ability to build relationships with team, peers and area leads

Demonstrated leadership in achieving shared objectives in a matrix organization

Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into Automation/digital solution

Proven track record of analytical skills, problem solving and attention to detail

Able to demonstrate our company's Leadership Principles and Enterprise Leadership High personal integrity, credibility, and energy

Strong technical writing capabilities

Strong written and verbal communication skills

Project Management Experience System validation and other Quality management functions

Experience with navigating/troubleshooting Process Control systems, with preferred experience with the following:
DeltaV DCS, Allen Bradly PLC, OPC, Siemens Step7, Modbus/Fieldbus/Profibus and other related technologies

Preferred

Understanding and ability to apply regulatory/compliance requirements relative to their role Networking, Virtual Machines, Database management and other general IT administration

Direct experience with SDLC and change controls for a GMP regulated process/system

Required Skills:

cGMP Guidelines, cGMP Regulations, DCS Configuration, Industrial Communication Protocols, Investigation Management, IQ OQ PQ, IT Systems Integration, Matrix Leadership, Matrix Management, Programmable Logic Controller (PLC), Systems Development Lifecycle (SDLC), Technical Project Management, Technical Writing, Troubleshooting Preferred

Skills:

Change Controls, Regulatory Management, Software Development Life Cycle (SDLC), Virtual Machines (VM)
Current Employees apply HERE Current Contingent Workers apply HEREUS and Puerto Rico Residents Only:

Our…