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)
Compensation
The primary location for this posting is: USA - Pennsylvania - West Point.
The salary range for the primary location of this role is: $117,000.00 - $184,200.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
Additional Details
•Employee Status: Regular
•Relocation: No relocation
•VISA Sponsorship: No
•Travel Requirements: 10%
•Flexible Work Arrangements: Hybrid
•Shift: 1st - Day
•Valid Driving License: No
•Hazardous Material(s): n/a
