Senior Specialist, Process Automation

BioSpace; West Point (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

BioSpace at the West Point site seeks a Senior Specialist in Process Automation to lead a small engineering team and support vaccine manufacturing via DeltaV, PLC, SCADA, and HMI systems.

You will drive SDLC and GMP-compliant improvements, mentor staff, and coordinate with IPT leaders to advance digital manufacturing initiatives across the organization.

Qualifications

• Bachelor of Science (BS) in Engineering, Computer Science, or related field.
• 7+ years in process automation, IT/OT, or equivalent.
• DeltaV DCS, PLC, SCADA, HMI, CSV, and SDLC experience.
• Strong technical writing capabilities.
• Knowledge of S88 Batch Standard.
• Knowlege of regulatory GxP requirements.
• Process validation knowledge and problem-solving skills.

Responsibilities

• Lead and mentor a team of two engineers in process automation support for a vaccine manufacturing facility.
• Prioritize workload while ensuring SDLC, GMP, safety, and environmental regulations compliance.
• Collaborate with Integrated Process Team through ownership of automated systems.
• 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 and maintain readiness for inspections.
• Foster a high-performing, collaborative team environment.
• Serve as SME for automation on the IPT leadership team.
• Communicate with business, technical, and quality reps through tier process.
• Support automation inquiries during audits/inspections; discuss automation with cGMP processes.
• Continuously evaluate systems and develop strategies to optimize quality and stability for future expansion or upgrades.
• Direct site and global digital transformation initiatives for West Point Digital Manufacturing Operations.

Skills

DeltaV DCS

PLC

SCADA

HMI

CSV

SDLC

S88 Batch

GxP compliance

Technical writing

Communication

Education

Bachelor of Science in Engineering

Job description

Our company is seeking a Senior Specialist in Process Automation to join our Digital Manufacturing Operations organization at the dynamic West Point site. We are committed to fostering an environment of mutual respect, encouragement, and teamwork. As part of our team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Join us in our mission to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

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

Required

• 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

• Pharmaceutical and Biotechnology manufacturing process experience is strongly preferred.