Technical Operations Contractor - II

The Operations Project Representative will serve as the primary Operations representative for packaging line installation projects, from early project concept through implementation and handover to routine operations. This role will:

• Learn and understand site operations processes and constraints
• Represent Operations in cross-functional project forums
• Act as the key point of contact between the project team and the Operations Manager
• Ensure operational requirements are embedded in project design, timelines, and deliverables
• Own operations-related implementation activities (SOPs, training, readiness, etc.)
• Qualification documentation approval.

Key Responsibilities

• Operations Representation & Project Participation
• Serve as Operations representative to ensure on-time new line installation, qualification and start-up inclusive of technical transfer activities associated with any products launching on the new line.
• Act as Operations subject matter expert (SME) for new packaging line installations and associated product transfers
• Attend PCR (Project Change Request) sub-team and other project meetings to define, document, and communicate Operations requirements.
• Serve as the main liaison between the project team and the Operations Manager, providing clear updates, risk escalation, and decision support.
• Assume ownership of Operations PCR tasks to ensure implementation timelines and milestones are met.
• Proactively identify operational risks/impacts (capacity, staffing, procedures, training, layout, safety, etc.) and drive mitigation plans.
• Attend Factory Acceptance Tests (FATs) as part of Operations representation for new equipment and packaging line installations.
• Procedures & Documentation
• Author, revise, and/or review Operations-related SOPs, work instructions, batch records, and supporting documentation required for new or modified processes.
• Ensure Operations procedures are aligned with cGMP requirements and internal quality standards.
• Coordinate with Quality, Engineering, EHS, and other functions to secure required reviews and approvals.
• Training & Readiness
• Develop and execute the Operations training strategy for new and existing packaging lines (operator and technician levels).
• Create or coordinate training materials (e.g., presentations, job aids, training guides) in collaboration with Operations and Learning and Development team as applicable.
• Plan and support training delivery to ensure operators are ready prior to go-live.
• Support operational readiness activities (e.g., machine trials, start-up support) to ensure a smooth transition to routine production.
• Coordination & Continuous Improvement
• Track and report status of Operations deliverables, action items, and risks within project timelines.
• Support continuous improvement by capturing lessons learned from product introductions and recommending process or documentation enhancements.
• Ensure alignment of Operations requirements with EHS, quality, and compliance expectations for new or modified equipment, processes, and layouts.

Education

• BS Degree in an engineering discipline or equivalent/comparable/applicable BS Degree.

Required Experience & Skills

• Working knowledge of cGMPs as they apply to the manufacturing and packaging industry.
• Strong technical writing skills and clear, concise verbal communication.
• Demonstrated ability to organize and manage multiple projects and priorities across different timelines.
• Ability to quickly learn new processes, systems, and technologies.
• Positive attitude, strong work ethic, ability to work under pressure and within tight timelines.
• Proven ability to work effectively in a team environment and collaborate cross-functionally (e.g., Operations, Engineering, Quality, EHS, Supply Chain).
• Strong Microsoft Office skills, especially Outlook, Excel, Word, and PowerPoint.

Preferred Experience & Skills

• Experience supporting capital projects, technology transfers, or new product introductions in a GMP manufacturing environment, specifically packaging line or device assembly capital projects.
• Experience developing SOPs, training materials, and/or executing training programs for manufacturing personnel.
• Familiarity with electronic document management and learning management systems.