Deviation Management Specialist - I (Assistant)

Location: West Point, Pennsylvania, United States. Site-based assignment requiring work at the site Monday through Friday; occasional remote work may be available but is not guaranteed.

Salary: $86,900 per year

Company

hirify.global provides staffing and technical personnel for engineering, manufacturing, and life sciences assignments.

What you will do

• Lead or support investigations into manufacturing deviations and prevent recurrence.
• Identify root causes, define corrective and preventive actions, assess product impact, and determine event scope.
• Provide technical support to vaccine manufacturing operations, including shop-floor problem solving and equipment troubleshooting.
• Manage investigation timelines, compliance due dates, escalations, and remediation plans.
• Support continuous improvement, process and equipment actions, validation, and change-control activities.
• Design experiments and author technical and manufacturing documentation, including investigation reports and protocols.

Requirements

• B.S. degree in Engineering or Sciences; an M.S. degree may be considered with the required experience.
• At least one year of post-bachelor’s experience supporting GMP manufacturing operations or GMP technical operations.
• Ability to drive results, meet assigned due dates, communicate effectively, collaborate, and maintain accountability.
• Strong problem-solving skills and ability to analyze safety, compliance, automation, equipment, process, and people factors.
• Ability to work onsite at the West Point site Monday through Friday; off-shift or weekend coverage may be required.

Nice to have

• Vaccine manufacturing or sterile processing experience.
• Technical writing experience for investigations, protocols, and technical reports.
• Experience with 5-Whys, fishbone analysis, or other investigative tools.
• Experience authoring investigations for atypical manufacturing events.

Culture & Benefits

• Work within a Technical Operations Deviation Management team supporting manufacturing.
• For temporary assignments lasting 13 weeks or longer, major medical, dental, vision, and 401(k) benefits may be available.
• Statutory sick pay is provided where required.