Associate Director-Automation Engineer (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 live virus bulk manufacturing facility, leading a team of automation engineers providing guidance and assistance for shop floor support, deviation investigations, change management, system administration, and management of small projects, and workload prioritization, technical oversight, and team development.

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

Key Functions

• Manage a team of automation engineers that provide process automation support to enable reliable and compliant supply of vaccines while achieving safety, quality, and environmental compliance.

• Establish priorities and work schedules with stakeholders (operations, technology, quality) and manage workload distribution for direct reports.

• Provide development plan and opportunities for direct reports through mentoring, on-the-job training, as well as official training.

• Lead and support in system upgrades, shop floor 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.

• Accountable for 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.

• Accountable for installation and qualification of new equipment into operations.

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

• Accountable for 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.

• Accountable for 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/automation requirements.

Education:

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

Required Experience and Skills:

• Minimum Seven (7) years in pharmaceutical process automation or equivalent

• Experience in Automation Platforms such as DCSs (DeltaV), PLCs (Allen Bradley, Siemens), SCADA, Data Historians (OSI PI), Batch Reporting (Informetric InfoBatch)

• Demonstrated ability to communicate effectively and to build relationships with team, peers and other 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.

• Strong understanding of aseptic and sterile operation.

• Experience in all aspects of GMP Change Control and Computer System Validation.

• 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 and managing teams.

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

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