Technical Manager – Manufacturing Applications

This is a fully remote position, open to applicants in United States.

📋 Description

• Take full ownership of the comprehensive management of GxP-regulated manufacturing systems, which includes lifecycle planning, enhancements, upgrades, rationalization, and decommissioning.

• Ensure that manufacturing systems adhere to GxP regulations, internal quality standards, and are prepared for inspections.

• Coordinate all aspects of validation planning, risk assessments, testing, documentation, change impact analysis, approvals, and deployments related to GxP system modifications.

• Collaborate with Quality, Manufacturing, and IT stakeholders to align operational needs with compliant system capabilities and enhancements.

• Supervise operational stability and performance, including incident management, root cause analysis, CAPAs, and initiatives for continuous improvement.

• Oversee vendors and service partners who support GxP systems.

• Maintain documentation that is inspection-ready and assist in internal and external audits as well as regulatory inspections.

• Organize training and user enablement to ensure effective system usage and ongoing compliance.

• Report directly to the Director of Software Engineering as part of the IT Manufacturing Applications team.

⛳️ Requirements

• Bachelor’s degree in Information Technology, Engineering, Life Sciences, or a similar field.

• A minimum of 4 years of experience in supporting or managing manufacturing IT systems within regulated environments.

• Proficiency in working with technically complex systems that involve integrations, automation, or custom implementations.

• At least 1 year of experience in a supervisory, management, technical lead, or team lead capacity.

• Strong knowledge of manufacturing systems, including MES, LIMS, QMS, instrument-related systems, or equivalent manufacturing platforms.

• Experience in IT service management and quality governance processes.

• Practical software development experience related to system integrations, automation, or platform enhancements.

• Proficiency in using C#, JavaScript/TypeScript, modern web frameworks like React, and API-based integrations.

• Experience in supporting manufacturing environments that are global or multi-site is an advantage.

• Familiarity with manufacturing digital transformation initiatives is a plus.

• Proven experience managing GxP-regulated systems, including validation support, compliance oversight, and change control, is preferred.

🏝️ Benefits

• Bonus/incentive pay eligibility

• Paid time off

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k)