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Senior Process Technician - Eurofins CDMO Alphora Inc.

Eurofins Canada BioPharma - 12 emplois
Oakville, ON
Temps plein
Niveau d`entrée
Avantages pour l'entreprise
Congés payés
Assurance invalidité
Company Description

Eurofins 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 -“API's”) 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.

Job Description
  • Execute chemical processing operations following batch record instructions to ensure the successful completion of batches.
  • Work in accordance with Environmental, Health and Safety Procedures, Standard Operating Procedures, Production Batch Records, Good Documentation Practices, and Good Manufacturing Practices.
  • Accurate and contemporaneous batch sheet entries
  • Second-person verification as required by production batch records
  • Work closely with the shift Team Leader to develop and assign daily activities to the team.
  • Work independently to complete daily tasks as assigned by the Team Leader on time and with “right the first time” approach.
  • Lead the shift in the absence of the Team Leader.
  • Support and mentor Jr team members to complete assigned tasks.
  • Support the Team Leader to review the quality of work being conducted by the team.
  • Provide practical training to Jr team members as required.
  • Participate in Line Clearance activities to support batch starts.
  • Equipment set-up and inertion of process equipment.
  • Execute and/or troubleshoot routine unit operations such as:
  • Filtrations
  • Phase separations
  • Refluxing operations
  • Atmospheric distillations
  • Reduced pressure distillations
  • Hydrogenations
  • Chromatography
  • Execute complex operations with limited support from the Team Leader (or designate).
  • Setting up and executing specialized operations with limited support from the Team Leader (or designate):
  • Hydrogenations
  • Biotage purifications
  • Pyrophoric material charges (i.e. nBuLi)
  • Cleaning of process equipment and facilities.
  • Starting and troubleshooting the plant utilities (starting up air compressors, vacuum system, chiller system, troubleshooting the air compressor, etc)
  • Support Engineering Preventive Maintenance program by performing reactor integrity tests.
  • Quarantining, sampling (batches and materials), and submission of samples (raw materials, IPC's and R&D samples) to Quality Control and Warehouse.
  • Reconciliation of batches to meet departmental KPI's
  • Staging/de-staging of batches as required.
  • Play a more active role supporting exception management and process improvement initiatives as required.
  • Review of Master Batch Record instructions as required.
  • Safe handling of all chemicals including process waste.
  • Other duties as assigned.

Additional:

  • Follow Environmental, Health and Safety rules/regulations and report any workplace injuries or accidents immediately.
  • Adhere to the policies and guidelines set out in the Alphora Employee Handbook.
  • Support Operations Leadership (e.g. Team Leader, Sr. Team Leader, Sr. Manager) as required to perform additional duties.

COMMUNICATION AND CONTACTS:

Within the Company

  • Interact with Operations Leadership and related department personnel for completion of daily tasks.
  • Interact with Technology Transfer, Quality Control, Quality Assurance, and Engineering/Maintenance as required.
  • Work harmoniously with all fellow employees.

Outside of the Company

  • Interact with Clients and/or GMP auditors as required.
  • Interact with various agencies as needed (e.g. environmental compliance, Insurance, WHMIS, HPB/FDA, municipal officials, public utilities, etc.)
Qualifications
  • Have a minimum of a College Diploma or Degree
  • Have 2+ years of experience in a chemical manufacturing facility with preference for cGMP experience
  • Have experience handling hazardous chemicals
  • Have experience working with API or formulation pharmaceutical processing equipment, or related experience in food, cosmetics or specialty chemicals
  • Have experience working with computerized chemical processing equipment
  • Have proficient written and verbal English communication skills
  • Be capable of multi-tasking
  • Be capable of sound decision-making
  • Have a solid understanding of cGMP principles with prior QA/compliance experience being a definite asset
  • Have good interpersonal skills
  • Have good time management skills
  • Have Good Documentation Practices (GDP)
  • Experience with shift work: 8 hour - 24/5 and/or 12 hour - 24/7 (Continental shift schedule)

Additional Information

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

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