Senior Operator – Eurofins CDMO Alphora Inc.

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 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

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Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs. In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its state-of-the-art organization, with continued investments in its people, modern facilities, equipment, and instrumentation.

Job Description

The Senior Operator is accountable to the Team Leader, Operations and conducts cGMP operations for processes in the Kilo Laboratory, Pilot Plant and the Warehouse. The Senior Operator role requires the candidate to be capable of working independently to execute daily work plans while performing complex chemical operations and supporting Junior Operators. The Senior Operator role will support the Team Leader, leading the shift when required.

DUTIES AND RESPONSIBILITIES:

Core:

• Accurate and timely batch sheet entries
• Batch sheet entry verification
• Set-up and inertion of process equipment
• Adherence to all relevant EHSP’s and SOP’s
• Cleaning of process equipment, facilities and warehouse
• Perform complex batch operations
• Supervise Operators and shift activities as required
• Ensure GMP compliance during operations – execution of batches to cGMP standards
• Ensure EHS measures are followed
• Confirm equipment setups
• Confirming that equipment status and supporting documentation is current and correct
• Review of all batch documents relating to shift activities
• Review of all log sheets relating to shift activities
• Ensure execution to maintain production schedules
• Oversee multi-shift activities and aid in planning
• Perform and Troubleshoot operations such as:
• o Extractions
• o Filtrations and product drying
• o Phase separations
• o Refluxing operations
• o Atmospheric distillations
• o Reduced pressure distillations
• o Hydrogenation
• Trouble shoot equipment performance
• Ensuring processes are executed as per SOP’s and Batch Sheets
• Ordering of consumables as required
• Training personnel and documenting the training

Additional:

• Receiving, quarantining, sampling, staging/de-staging, packaging and shipping materials/products as required
• Participate in SOP, cGMP and Health and safety training sessions. Ensure all trainings are documented in a timely manner
• Initiate change control as required
• Complying with scheduled operations activities
• Interact with cGMP auditors as required.
• Other duties as assigned/required

Qualifications

• Education: Diploma/Bsc/Msc/ with minimum 5+ year experience in Chemical /Pharmaceutical/Food manufacturing environment
• Experience with shift work: 8 hour – 24/5 and/or 12 hour – 24/7 (Continental shift schedule).
• Good GMP working knowledge in a Chemical/Pharmaceutical (API) environment
• Good Documentation Practices (GDP)
• Experience in leading a shift

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