Senior Specialist, Engineering

Job Summary

Senior Specialist – Engineering, West Point Technical Operations. This role provides technical support and leads continuous improvement initiatives within the lyophilized vaccine manufacturing area at the West Point Processing Facility, ensuring operational excellence, compliance, and process performance.

• Provide technical support to the Lyophilization manufacturing area.
• Implement continuous improvement projects and support equipment investigations.
• Work as an individual contributor, team member, or project lead.
• Author or approve Change Control documentation for process, validation, analytical, equipment, facility/utility and automation changes.
• Manage on‑time implementation and close‑out of projects to meet production and supply timelines.
• Escalate potential delays and develop remediation plans.
• Apply advanced technical skills to align activities with department, site and franchise objectives.
• Support, execute, or lead projects that increase compliance, simplify processes, standardize activities, and gain efficiencies.
• Examine complex issues from safety, compliance, automation, equipment, process and people perspectives to identify root causes.
• Provide advanced technical support for manufacturing, including troubleshooting process and equipment problems.
• Design, conduct and review experimental protocols using Technical Operations lab facilities and/or production equipment.
• Monitor process health through continuous monitoring, annual process reviews and continuing validation activities.
• Author and update technical documentation for investigations, process design, engineering studies and validation.
• Prepare documentation to support regulatory submissions and participate in regulatory inspection activities.
• Provide on‑floor support for complex operational and technical issues.
• Conduct and approve deviation investigations to prevent recurrence and assess product impact.
• Lead projects that improve process performance, including CAPA, right‑first‑time initiatives, and value capture projects.
• Support team safety, environmental and compliance objectives.
• Collaborate with coaches, operators, mechanics, support groups, quality, planning, project teams and external vendors.

• Education: B.S. in Engineering or related technical field (or higher).
• Experience: Minimum six years post‑bachelor’s in a GMP functional area (operations, Technical Operations, Technology, Engineering or Maintenance).
• Experience in deviation management and/or change control, equipment support or project support.
• Experience in vaccine or biologics manufacturing within a cGMP environment.
• Experience authoring technical documentation in a cGMP context.
• Proven leadership with influence, communication, teamwork and strategic planning skills.
• Experience with data analytic tools (Spotfire, Pipeline Pilot, MANTIS, Power BI, JMP, etc.).
• Strong knowledge of GMP, manufacturing execution systems, MES, process validation, continuous monitoring, root cause analysis and quality risk assessment.

• Experience authoring complex process change control.
• Experience in lyophilization of biologics or vaccines in sterile cGMP facilities.
• Experience remediating product performance (potency) issues.
• Experience with Manufacturing Execution Systems (MES).
• Experience responding to regulatory questions and presenting technical subjects to agencies.
• Background in Chemical, Mechanical, Biomedical or Biological Engineering.

Salary range: $ – $, based on experience, education and location. Eligible for annual bonus and long‑term incentive when applicable.

Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days, and additional insurance options.

Our company is an equal opportunity employer and provides equal opportunities to all employees and applicants for employment. Discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other protected characteristics is prohibited. The company complies with affirmative action requirements for veterans and people with disabilities.