Senior Specialist, Manufacturing Automation

About the role

The Senior Specialist, Automation plays a crucial role in the Focus Factory Automation team, supporting manufacturing operations in Durham, NC. This position focuses on ensuring the reliability, performance, and compliance of critical process control systems in an aseptic manufacturing facility.

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.
• 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.

Qualifications

• 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.
• Demonstrated 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.

Preferred Skills

• Data Integrity Acumen.
• Leverage Lean Manufacturing /Six Sigma methodology.

Required Skills

• Allen Bradley PLC.
• Animal Vaccination.
• Audit Management.
• Automation Engineering.
• Biopharmaceutical Industry.
• Business Process Improvements.
• Data Integrity.
• Data Management.
• Digital Manufacturing.
• Emerson DeltaV.
• Global Manufacturing.
• GMP Compliance.
• Pharmaceutical Microbiology.
• Problem Management.
• Production Support.
• Quality Management.
• Real-Time Programming.
• Software Development Life Cycle (SDLC).
• Technical Leadership.
• Technical Writing Documentation.
• Veterinary Medicine.