Production Supervisor – Fermentation / Superviseur(e) de production – Fermentation

Job Description:
To support in the production process of veterinary biologics according to a defined production schedule following cGMP guidelines and specific Outlines of Production to meet market demands for aquaculture products.
Main Responsibilities and Duties
GMP Responsibilities:
Review and approve completed batch records to ensure production records are evaluated and signed by an authorized person.
Ensure facilities, equipment, and production areas remain in a qualified, validated, calibrated, and well-maintained state, including oversight of cleaning, maintenance activities, and associated records.
Maintain plant hygiene standards and review relevant documentation, including logbooks.
Ensure all team members receive and maintain required GMP training, including approval of instructor-led and on-the-job training (OJT).
Ensure timely communication and escalation of quality issues through established processes.
Initiate, classify, investigate, and document Reliance Events, serving as Lead Investigator when required.
Act as Change Manager for changes impacting the department and ensure compliance with change control procedures.
Prepare and revise GMP documentation including SOPs, master batch records, batch records, and other controlled documents.
Ensure compliance with applicable GMP regulations, quality standards, and site requirements.
May be delegated responsibility to temporarily perform the duties of the Operations Manager (IPT).
Participate in required medical assessments in accordance with GMP regulations and site requirements.
Operations Responsibilities:
Promote and model a "Safety First, Quality Always" culture and ensure compliance with all company safety, quality, cGMP, SOP, and manufacturing requirements.
Ensure products are manufactured according to approved product dossiers and production requirements to meet business and market demands.
Maintain a strong shop floor presence and provide leadership through technical expertise, problem-solving, continuous improvement, and process optimization.
Act as the facility owner for assigned areas, taking accountability for operational performance and activities.
Support production planning by providing input to schedules, monitoring execution, and tracking adherence.
Manage shift coverage, short-term absences, attendance tracking, and workforce allocation.
Conduct regular one-on-one meetings, performance evaluations, coaching, mentoring, and development discussions with direct reports.
Build and maintain training plans to ensure work is performed by trained and qualified personnel.
Ensure accurate and timely completion, review, and approval of production documentation, including batch records and SAP transactions such as material consumption.
Investigate operational events using structured root cause analysis methodologies and document findings in Reliance.
Implement operational improvements and minor process changes through established change control procedures.
Provide input into User Requirement Specifications (URS) and support capital projects as required.
Facilitate daily Tier 1 meetings and support Tier 2 management processes, including updating performance boards and facilitating meetings when required.
Escalate significant operational issues and proposed solutions to the Operations Manager (IPT).
Perform other duties as assigned.
Minimum Qualifications
Education:
College Diploma in a Life Science discipline such as Biochemistry, Chemistry, Biology, Chemical Engineering, or Biochemical Engineering preferred.
Experience:
3 to 5 years of experience in a manufacturing environment; GMP experience preferred.
Experience in fermentation manufacturing preferred
Previous supervisory or people leadership experience preferred.
Experience conducting investigations, writing deviations, CAPAs, SOPs, and other GMP production documentation.
Strong understanding of quality systems, cGMP requirements, and regulatory expectations.
Technical Skills:
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
Experience with SAP or other ERP systems preferred
Experience in bacterial fermentation manufacturing preferred
Strong written and verbal communication skills
Excellent interpersonal and collaboration skills
Additional Requirements:
Must be available on-call up to 12 hours per day, 7 days per week for emergency situations.
Must be able to read, write, understand, and comply with applicable standard operating procedures.
This job posting is for an existing vacancy position.
We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.
Required Skills:
Adaptability, Analytical Problem Solving, Cleanroom Gowning, Cleanroom Operations, Computer Literacy, Data Analysis, Equipment Maintenance, Good Manufacturing Practices (GMP), Inventory Management, Master Batch Records, Process Optimization, Production Scheduling, Shift Work, Sterile Filling, Teamwork
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Soutenir le processus de production de produits biologiques vétérinaires selon un calendrier de production défini, en conformité avec les lignes directrices des BPF (cGMP) et les protocoles de production établis, afin de répondre à la demande du marché pour les produits destinés à l’aquaculture.
Principales responsabilités et fonctions
Responsabilités liées aux BPF (Bonnes Pratiques de Fabrication):
Examiner et approuver les dossiers de lot complétés afin de s’assurer que les dossiers de production sont évalués et signés par une personne autorisée.
Veiller à ce que les installations, les équipements et les zones de production demeurent qualifiés, validés, étalonnés et adéquatement entretenus, y compris la supervision des activités de nettoyage, d’entretien et de la documentation associée.
Maintenir les normes d’hygiène de l’usine et examiner la documentation pertinente, y compris les registres de bord.
S’assurer que tous les membres de l’équipe reçoivent et maintiennent la formation requise en matière de BPF, y compris l’approbation des formations en classe et de la formation pratique en milieu de travail (OJT).
Assurer une communication et une escalade rapides des enjeux liés à la qualité conformément aux processus établis.
Initier, classifier, enquêter et documenter les événements Reliance, et agir à titre d’enquêteur principal lorsque requis.
Agir à titre de gestionnaire de changement pour les modifications ayant une incidence sur le département et veiller au respect des procédures de contrôle des changements.
Préparer et réviser la documentation BPF, notamment les procédures opératoires normalisées (PON/SOP), les dossiers maîtres de lot, les dossiers de lot et autres documents contrôlés.
Assurer la conformité aux exigences réglementaires applicables, aux normes de qualité et aux exigences du site.
Peut se voir déléguer temporairement les responsabilités du gestionnaire des opérations (IPT).
Participer aux évaluations médicales requises conformément aux règlements BPF et aux exigences du site.
Responsabilités opérationnelles:
Promouvoir et incarner une culture axée sur « La sécurité avant tout, la qualité en tout temps » et assurer le respect des exigences de sécurité, de qualité, des BPF, des SOP et des procédures de fabrication.
Veiller à ce que les produits soient fabriqués conformément aux dossiers d’enregistrement approuvés et aux exigences de production afin de répondre aux besoins du marché et de l’entreprise.
Maintenir une présence active sur le plancher de production et exercer un leadership fondé sur l’expertise technique, la résolution de problèmes, l’amélioration continue et l’optimisation des procédés.
Agir comme responsable des installations pour les secteurs assignés et assumer la responsabilité des activités et de la performance opérationnelle.
Contribuer à la planification de la production en participant à l’élaboration des horaires, au suivi de l’exécution et au respect du ca

Skills
Artificial Intelligence, Data Analysis, Excel, Inventory Management, ERP, SAP, Documentation