Senior Specialist, Manufacturing Automation

MSD•Durham, NC

20h•$117,000 - $184,200•Hybrid

About The Position

At our company, we aspire 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 Digital Manufacturing Operations team and be part of a dynamic environment where you can make a significant impact on the quality and efficiency of our manufacturing processes. The Senior Specialist, Automation is a key member of the Focus Factory Automation team supporting manufacturing operations in Durham, NC. In this role, you will serve as the lead automation engineer for an aseptic manufacturing facility, ensuring the reliability, performance, and compliance of critical process control systems. Responsibilities include troubleshooting complex automation issues, implementing process control and data collection solutions, and supporting manufacturing operations while adhering to SDLC, GMP, safety, and environmental requirements. This position works closely with Manufacturing, Quality, Engineering, and IT teams to support a wide range of automated systems across the facility. The role provides technical leadership through leading cross-functional initiatives, mentoring automation team members, supporting the Automation Lead, and serving as a subject matter expert for automation systems. It also offers the opportunity to drive continuous improvement, implement new technologies, and make a meaningful impact on manufacturing performance and product quality.

Requirements

Bachelor’s degree or higher in Engineering or Computer Science
Minimum five (5) years of experience in a production regulated industry
Minimum of five (5) years of experience in a GMP manufacturing automation-related role and direct experience with SDLC and change controls
Direct experience with at least two of the three platforms: Emerson DeltaV, Allen Bradley PLC (or equivalent), and PI (or equivalent)
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 solutions
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
Excellent communication and influencing skills
Strong written and verbal communication skills in English

Nice To Haves

Data Integrity Acumen
Lean Manufacturing /Six Sigma methodology

Responsibilities

Provide technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of the product and on-time project execution.
Offer production shop floor support as needed.
Apply sound project management techniques to meet schedule, budget, benefit realization, and other project objectives.
Provide technical guidance/support including authoring or reviewing and approving system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processes.
Serve as the subject matter expert for regulatory inspections and audits and other validation activities.
Ensure compliance with GMPs, safety, and environmental regulations by periodically reviewing automation documents, preventive maintenance, and SOPs.
Assist in the development, review, and approval of department SOPs and other site GMP SOPs related to automation and digital activities.
Develop and support corrective actions associated with automation-related deviations/investigations.
Communicate periodically with immediate supervisor about the status of the area of responsibility.
Support digital innovation initiatives on an as-needed basis.
Initiate and lead collaboration within the Operations, Quality, and Technical organizations to resolve complex problems.
Use technical knowledge to assure the efficient operation of various automated processing and information technology systems.
Lead in installing and placing new equipment into operations and develop solutions for automation problems.
Oversee investigations of automation anomalies to prevent recurrence.
Provide on-floor support of manufacturing activities and periodic 24 x 7 on-call support.
Identify and implement process/equipment improvements and manufacturing efficiencies.
Maintain technical documentation.
Provide client services support for business area applications.
Serve as liaison with corporate and divisional automation and IT groups.