Senior Specialist, Process Automation

About the role

This role will lead a team of engineers in providing automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe.

Responsibilities

• Lead and mentor a team of two engineers in providing process automation support for our Hepatitis A vaccine manufacturing facility to enable reliable and compliant manufacturing/supply of vaccines.
• Direct and prioritize workload activities of the process automation team, ensuring compliance with System Development Life Cycle (SDLC), GMP, safety, and environmental regulations.
• Collaborate with other functions within the Integrated Process Team through ownership of automated systems and Subject Matter Expertise.
• Support manufacturing activities on the shop floor.
• Design and implement process control improvements and corrective actions.
• Troubleshoot and resolve automation issues and events.
• Participate in deviation investigations.
• Administer automated control systems, sustaining a state of Permanent Inspection Readiness.
• Apply leadership skills to foster a high-performing, collaborative team environment.
• Serve as the primary Subject Matter Expert and represent the automation function on the IPT leadership team.
• Communicate daily with business, technical, and quality representatives through the tier process.
• Support process automation inquiries during internal and external audits/inspections, speaking knowledgeably about automation in association with cGMP processes and manufacturing operations.
• Continuously evaluate automated systems and develop strategies to optimize and ensure quality and stability of systems through future expansion, replacement, or upgrade.
• Directly support site and global initiatives with respect to digital transformation and improving how West Point Digital Manufacturing Operations does business.

Qualifications

• Bachelor of Science (BS) degree in Engineering, Computer Science, or related field.
• Seven or more (7+) years in process automation, IT/OT, or equivalent.
• Technical and operational expertise in DeltaV DCS, PLC, SCADA, HMI, Computer System Validation (CSV), and System Development Lifecycle (SDLC).
• Strong technical writing capabilities.
• Knowledgeable of S88 Batch Standard.
• Knowledgeable of regulatory GxP requirements.
• Knowledge of equipment and process validation.
• Problem-solving skills (technical and non-technical).
• Strong communication and interpersonal skills to interface effectively with colleagues from all levels of the organization, and with external customers and vendors.

Preferred qualifications

• Pharmaceutical and Biotechnology manufacturing process experience is strongly preferred.

Required skills

• Audit Management
• Biotechnology
• Business Process Improvements
• Computer Science
• Data Management
• DeltaV DCS
• Digital Manufacturing
• Digital Transformation
• GMP Compliance
• GxPs
• Pharmaceutical Microbiology
• PLC Logic
• Problem Management
• Process Automations
• Process Control
• Process Manufacturing
• Quality Management
• Real-Time Programming
• Shop Floor Management
• Software Development Life Cycle (SDLC)
• Systems Development Lifecycle (SDLC)

Pay

The salary range for this role is $117,000.00 - $184,200.00. 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.

Benefits

• Annual bonus and long-term incentive, if applicable
• 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

Schedule

• Flexible Work Arrangements: Hybrid
• Shift: 1st - Day
• Travel Requirements: 10%