Sr. Process Engineer - Eurofins CDMO Alphora, Inc.

Exciting growth plans! Eurofins CDMO Alphora is looking for a Sr. Process Engineer to join our dynamic team.  This is a unique opportunity to influence and create inputs in API, Drug Product and Biologics manufacturing processes under one roof.

As a Sr. Process Engineer, you will facilitate the development, implementation and continuous improvement of the processes and systems that ensure Alphora’s optimal efficiency, safety and cGMP compliance.

Your duties will include:

 Capital Projects:

• Identifies, justifies, and implements projects involving facility upgrades, capacity increases, process improvements, and automation to improve processes, equipment and buildings
• Oversees complete project cycle from feasibility studies, capital budget approval, creating bid specifications, selection of vendors and suppliers, installation support, commissioning, start-up, validation support, production hand over and final training.

Qualification:

• Prioritizes and schedules validation activities according to the validation master plan.
• Writes qualification protocols, and determines required qualification testing based on GMP requirements.
• Writes operational, cleaning and maintenance SOPs for all new qualified equipment.
• Analyzes and reviews calibration data and write reports on results.
• Tracks, maintains & investigates validation deviations, and CAPAs.

Process Engineering:

• Provides process engineering support to all areas for expeditious troubleshooting and resolution of equipment breakdowns, production delays, and quality issues.
• Investigate and collect data on operations problems, prepare and submit plan for their resolution.  Upon approval, carry the project to completion.
• Develop, analyze and implement continuous improvement ideas to meet long term required cost reductions and increased profitability.
• Assist with process engineering as required to support “Batch” efforts.

Additional

• Five to ten years of experience in similar role in GMP environment
• Liaise with external and internal resources such as Research and Development, Analytical Services, Quality Assurance, Quality Control during implementation of the new processes or system
• Research and introduce as appropriate any new or existing technologies that facilitate process or system optimization
• Monitor, analyse and report on process and system data 
• Consult on the development of efficient process and system related engineering documentation including Standard Operating Procedures (SOP’s) and process flows