Technical Operations Specialist

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.

Position Overview - Basic Functions & Responsibility

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.