Associate Process Engineer, Prep Services Specialist

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

The Associate Process Engineer, Prep Service Specialist, works in a hands-on capacity in a fast-paced, cGMP environment and production support areas to process sterile and aseptic products. The specialist works in collaboration with Operations, Maintenance, Engineering, Supply Chain, Quality Assurance, and Pharmaceutical Technology and Validation for successful repeatable day-to-day manufacturing operations in the Prep Services Area. The role operates and supports one or more of these manufacturing departments: Formulation, Filling.

Position is responsible for planning and coordination of component processing. Position also facilitates maintaining departmental documentation and processing of batch documentation. Position is also trained to perform verification of process steps in support of departmental supervision. Knowledge of cGMP’s is essential to successful performance of the position. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Primary focus is to assure proper use and function of automated technology with complex operating systems, electronic interfaces, and validated data collection systems. The role works within manufacturing ensuring operational up-time, continuous improvement and innovation; leads production personnel throughout operations set-up, assembly, troubleshooting, and personnel training. During active operation, Off-shift or weekend coverage occasionally required to support the production schedule, technical team, or project-specific assignments.

Collaboration occurs within team framework of dedicated specialists who strive to understand, monitor, improve and support manufacturing processes throughout the facility. While focus is on day-to-day activities, there are opportunities to support strategic projects. The overall team ensures the facilities operate Right-First Time in a cost-effective manner, with on-going operational activities, and meeting the financial/timeline requirements. This role requires daily problem solving with other Technical groups, Maintenance, Validation, Operations, and Quality as well as equipment manufacturers and suppliers. A well-qualified candidate must have good analytical, trouble-shooting, problem solving, and communication skills; authors and revises manufacturing and process equipment documentation and is responsible for supporting validation and development work.

Specialist must qualify the company Aseptic gowning and process requirements and maintain this qualification annually for the position.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

No direct reports, direct interface leading lines in Inspection/Packaging in Rochester, MI plant

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Operational Engineering

• Participates in the design, development, and implementation of methods and systems to ensure process control, product quality, and availability of components and equipment 2 days prior to scheduled need date.
• Leads production personnel throughout set up, assembly, trouble-shooting, and personnel training; monitors production.
• Drives production pace, reduction in downtime; addresses equipment/component related problems that may result in yield losses, product or material waste
• Supports work completion in compliance with approved SOPs, SAP transactions, batch records, KPIs and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
• Maintains departmental documentation such as eLUMAC, current SOP’s and Work Instructions and other forms.
• On occasion, schedule and train union colleagues for more efficient performance in their assignment and cr