Operator Level Iii

6 days ago

Oakville, Canada Eurofins Canada BioPharma Full time

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 just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1,000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing._**

**_ In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years._**
- __________________________________
- 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 Operator Level III is accountable to the Team Leader, Operations and conducts cGMP operations for processes in the Kilo Laboratory, Pilot Plant and the Warehouse. The Operator Level III is a senior level position which can perform complex operations with mínimal supervision. In the absence of a Team Leader the Operator Level III would be expected to lead the shift.

**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
- Direct operations 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’s, cGMP and HS&E training sessions and ensure all trainings are documented in a timely manner
- Generate CCRF’s as required
- Complying with scheduled operations activities
- Other duties as assigned/required

**COMMUNICATION AND CONTACTS**:
**Within the Company**
- Interact with all Personnel throughout the Alphora to ensure the timely and safe execution of processes.

**Outside of the Company**
- Interact with cGMP auditors as required.
- Interact with various agencies as needed (i.e. environmental compliance, Insurance, WHMIS, HPB/FDA, municipal officials, public utilities, etc.)

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
- Experience in leading a shift

Additional Information

At Eurofins we offer excellent full-time benefits including

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