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
- Years of experience: 7+
- Educational background: Mechanical/Chemical Engineering BSc
- Industry background: Pharma/food/ cosmetic
- System/Software experience: AutoCAD/MS Project/ Microsoft Office
At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.
Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.
As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca
We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.
NO AGENCIES, CALLS OR EMAILS PLEASE
