Process Engineer

Position Summary

The Operations Project Representative serves as the Operations lead for packaging line installation, qualification, and product transfer projects within a GMP manufacturing environment. This role acts as the primary liaison between Operations and cross-functional teams to ensure new equipment, processes, and products are successfully implemented and transitioned into routine production.

Key Responsibilities

• Represent Operations on packaging line installation, qualification, start-up, and product transfer projects.
• Serve as the primary point of contact between project teams and Operations leadership.
• Participate in cross-functional meetings to communicate operational requirements and project updates.
• Identify operational risks and support mitigation plans related to staffing, capacity, procedures, training, safety, and facility layout.
• Attend Factory Acceptance Tests (FATs) and support equipment installation and commissioning activities.
• Author, review, and update SOPs, work instructions, batch records, and operational documentation.
• Ensure procedures comply with cGMP requirements and internal quality standards.
• Coordinate documentation review and approval activities with Quality, Engineering, EHS, and other stakeholders.
• Develop and execute training plans for operators and technicians on new equipment and processes.
• Support operational readiness activities, machine trials, and production start-up efforts.
• Track project milestones, deliverables, risks, and action items to ensure on-time implementation.
• Support continuous improvement initiatives by capturing lessons learned and recommending process enhancements.
• Approve qualification documentation and ensure compliance with quality and regulatory requirements.

Required Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Knowledge of cGMP requirements within manufacturing and packaging environments.
• Strong technical writing, communication, and organizational skills.
• Ability to manage multiple projects and priorities simultaneously.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Experience working effectively in cross-functional teams.

Preferred Qualifications

• Experience with capital projects, technology transfers, new product introductions (NPI), or packaging line installations.
• Experience developing SOPs, training materials, and conducting manufacturing training.
• Familiarity with electronic document management systems (EDMS) and learning management systems (LMS).