Job Description

Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -\xe2\x80\x9cAPI\xe2\x80\x99s\xe2\x80\x9d) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.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\xe2\x80\x99s 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 \xe2\x80\x9cBatch\xe2\x80\x9d 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\xe2\x80\x99s) and process flows

Qualifications

• Years of experience: 7+
• Educational background: Mechanical/Chemical Engineering BSc
• Industry background: Pharma/food/ cosmetic
• System/Software experience: AutoCAD/MS Project/ Microsoft Office

Additional InformationAt 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 .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 atWe 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

Eurofins