Ceva is seeking a Bioprocess Engineer/GID Technical Leader who will lead the transfer & process/methods improvement/development of vaccine batches.
About Us
Ceva Animal Health Canada established itself in Canada with the acquisitions of CentaurVA Animal Health and Vetech Laboratories in October 2011. Our Canadian presence expanded during 2019 when we acquired IDT Biologika subsidiary Gallant Custom Laboratories manufacturer of autogenous vaccines.
Ceva offers an expanding range of products for companion animals, poultry, swine, and ruminants for Canadian customers.
About the Job
We are currently seeking a Bioprocess Engineer/GID Technical Leader who will lead the transfer & process/methods improvement/development, with a one to three years vision, from technical development vaccine batches until the first commercial vaccine batches manufacturing, liaising with associated departments (R&D, industrial...).
Responsibilities
Industrialization strategy definition and management
- Participate in the definition and ensure implementation of transfer & process/methods improvement/development rationales (including technical, financial and regulatory aspects) to anticipate industrial needs.
- Define process validation strategy.
Batch manufacturing preparation
- Check and approve process/analytical validation protocol and manufacturing & testing instructions.
- Lead meetings with R&D, Industrial and Purchasing to implement an industrialization process.
- Define industrial process & analytical manufacturing tools.
- Coordinate contracts liaising with Global External Manufacturing & legal teams.
- Carry out QC methods and reagent transfers to Official Medicines Control.
- Write process validation protocols and manufacturing instructions.
- Write technology and analytical transfer
Risk assessment
- Participate in risk assessment meetings with R&D, GMSQ and Purchasing teams to identify & define critical process parameters and critical quality attributes, systems suitability evaluation.
- Confirm/evaluate that the lab process, formula and analytical methods are scalable.
- Manage preventive maintenance activities.
Process Improvement
- Evaluate/analyse process performance (KPIs, CQAs, CCPs) for process/methods improvement.
- Exchange with other GID units and contribute to process improvement through sharing and promoting best practices.
- Manage and realize dedicated process improvement related analysis, experiments, implementation tasks.
- Seek, evaluate and implement new production and analytical technologies in contact with internal/external experts.
Batch manufacturing
- Schedule batch manufacturing with logistics manager / CMOs.
- Ensure that resources are allocated to attend the manufacturing. For Pharma only: Check and approve validation report.
- Review manufacturing/analytical instructions (approve them for Pharma).
- Ensure that a new product meets COGS expectations.
- Prepare documentation for production authorization requests, GMO permits.
Training & Tech transfer
- Write and execute technical and analytical transfer reports.
- Run training sessions.
- Lead lessons learnt meetings after key industrialization milestones (knowledge management & process improvement).
Production & R&D support
- Propose trials to be performed for new raw materials sourcing implementation or process manufacturing changes/analytical methods in the frame of change control activities.
- Provide expertise to production, early R&D, QA and RA teams as manufacturing process/ industrialization expert for process improvement, optimal solution proposition and Capex evaluation.
- Provide data (BoM,) for COG calculations.
Lab management
- Manage laboratory activities according to priorities (new equipment purchasing, budget, resource allocation, Capex...).
- Ensure that relevant quality & EHS standards/rules and operating protocols & documentations for GID laboratories are followed.
Internal audit & inspection
- Answer all internal audit & inspections queries from the authorities related to defined activities.
- Update and write GMP procedures.
- Implement corrective and preventive actions.
About You
- You have a Master's Degree in Chemical Engineering or Biomedical engineering
- You have at least 3 Years' experience in cGMP biological production
- You have strong interpersonal skills with the ability to motivate others and influence decisions
- You have the ability to navigate and be successful in a complex, highly matrixed work environment.
- You have the ability to implement process improvements to manufacturing operations by way of proper corrective and preventive action (CAPA’s)
- You have demonstrated performance in Change Management, including evidence of successful implementation improvement initiatives impacting people, products, and processes
- You enjoy working with a team
- You are able to read, write, and communicate in English
- You have strong analytical and problem solving abilities
Ceva Animal Health - Canada is committed to accommodating any applicant with a disability, as required by law, during the recruitment, assessment and selection process. Please notify us if you require accommodation.
We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
Job Types: Permanent, Full-time
Benefits:
- Casual dress
- Company events
- Dental care
- Disability insurance
- Discounted or free food
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
Schedule:
- Day shift
- Monday to Friday
- Weekends as needed
Ability to commute/relocate:
- Guelph, ON N1K 1A8: reliably commute or plan to relocate before starting work (required)
Work Location: In person
