Associate Director Manufacturing Automation (On-site)

Job Description

The Associate Director Manufacturing Automation in Digital Manufacturing Operations is responsible for management of all automation process control systems in a vaccine manufacturing facility.

The Associate Director will lead a team of automation engineers providing all necessary support for the facility including on the floor support, deviation investigation, change management, system administration, and management of small projects. The Associate Director will be responsible for work prioritization, technical oversight, and team development.

The successful candidate will have the opportunity to apply their enthusiasm, technical skills, and leadership skills as a member of a multidisciplinary team supporting vaccine manufacturing. 

Key Functions

• Lead team to achieve Safety, Quality, and Environmental compliance excellence in all assignments

• Manage workload and skills development for direct reports

• Establish priorities and work schedules with stakeholders (operations, technology, quality)

• Understand and support all GMPs, safety, and environmental regulations

• System upgrades, troubleshooting issues, identifying trends, process monitoring, system administration, documentation updates, data querying, operator training and participating in deviation investigations

• Ensure automation documents, preventive maintenance, periodic reviews, and SOPs are in an inspection-ready state

• Support process automation inquiries during internal and external audits/inspections and must, therefore, be able to speak knowledgeably about automation, process and cGMP details of the manufacturing operations

• Evaluate automated and information technology systems and develop strategies to optimize and ensure the quality and stability of automation systems through future expansion, replacement, or upgrade

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

• Lead in installation and qualification of new equipment into operations

• Develop solutions for automation problems

• Participate and contribute to investigations of automation anomalies to prevent a recurrence, which includes on-the-floor support of manufacturing activities

• Lead in the development of technical requirements, keeping in mind the associated technology needs, benefits, and risks

• Analyze complex business requirements using tools and techniques and identifies internal/external solutions to meet these requirements

• Lead in developing control strategies and applying computerized tools that will deliver tangible improvements to overall production unit performance

• Communicate daily with the business, technical, and quality representatives within the area of support through the tier process

• Provide off-site weekend/evening automation phone or on-site support on a rotational basis

• Familiar with lean manufacturing principles with an ability to convert business logic and requirements into detailed system requirements

Education:

• Bachelor's degree in engineering, Science, Information Technology or other relevant discipline

Required Experience and Skills:

• 9 years in process automation or equivalent

• Experience in Automation Platforms such as DCS's (DeltaV), PLCs (Allen Bradley, Siemens), SCADA, OSI PI, Batch Reporting (Informetric Info Batch)

• 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

Preferred Experience and Skills:

• Experience with Computer System Validation

• Experience working in a cGMP environment

• Experience leading or managing teams

• Networking, Virtual Machines, Database management and other general IT administration.

• Experience in biologics, vaccine or bulk sterile manufacturing facilities.

NOTICE FOR INTERNAL APPLICANTS

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