This position is responsible for GMP/BPF and regulatories activities for the Facilities & Engineering department: document follow-up, deviation management, exchange controls, SOP and CAPA. This position works closely with the QA department. The follow-up of periodic verifications and regulatory watch concerning utilities and premises is part of the role (define budget, following operation, tracability of the document,…)
Responsibilities:
- Have overall responsibility for the operating and monitoring program for production areas and GMP critical utilities including water for injectable (WFI), pure steam, GMP process gases, all GMP activities (cleaning,...) and the environmental control program (pest control,...).
- Guarantee traceability of the life cycle of each piece of equipment, from its creation (SAT, SOP to be set up, etc.) to its maintenance, and its destruction in the system if obsolete.
- Ensure GMP compliance in the Facilities & Engineering department.
- Monitor and lead investigations into plant and equipment deviations and system failures and be responsible for implementing corrective/preventive actions (CAPA) and change controls for GMP systems.
- Monitor all compliance action plans (non-conformities, continuous improvement, etc.) involving the team, and hold follow-up meetings.
- Monitor maintenance and metrology programs and ensure that scheduled activities are carried out on time and documented.
- Train, document, audit and regularly inspect our suppliers for GMP activities (carry out contradictory inspections of our service providers) and draw up GMP referencing plans for our service providers.
- Validate documents relating to new equipment: specifications, functional analysis, SAT, reports, etc. and manage the traceability of DOEs.
- Establish and monitor key performance indicators (to be defined with the manager) and participate in daily meetings.
- Carry out, monitor and ensure compliance with written procedures relating to safety requirements, cGMP practices, standard operating procedures, and ensure traceability of operations (implementation of SOPs, follow-up sheets, paper or electronic logbook, job plan, etc.).
- Guarantee technical documentation for static SATs and participation in IQs.
- Participate in the definition of GMP requirements during work.
- Participate to the audits (regulatories
- Update and monitor the department's GMP documents in the electronic document management system (GED: Compliance Quest) and monitor updates to documents relating to the ANSM technical note.
- Ensure that information relating to GMP data (QBMS) is fed into the GTC/GTB system.
- Responsible for managing periodic checks and compliance of all equipment on the site: set up periodic inspection contracts, monitor planning, draw up and monitor the budget, traceability in the CMMS, carry out compliance monitoring, planify
Non-exhaustive list:
- Electrical installations (thermography, cabinet inspection, etc.)
- Pressure equipment
- Mechanical and lifting equipment.
- Fire safety systems
- Energy and fluid networks
- Control of hydraulic networks
- Reinforce the Facilities & Engineering department according to the needs of the department and to be validated by the manager
Qualifications and Education Requirements:
- Master’s degree in Facilities Management, Facilities Engineering or related qualification
- 7+ years of experience in a GMP environment with demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a biologic manufacturing environment, including process, equipment and facility validation experience
Preferred Qualifications:
- Experience with change control and validation related to GMP utilities and equipment
- Practical knowledge of eQMS and CMMS
- Working knowledge of utilities and mechanical systems
- Working knowledge of procurement and contracts
- Knowledge of health, safety and environmental regulations
- Experience in maintenance and all facets of facility operation
- Excellent verbal and written communication skills
- Possess planning, organizational, problem-solving and negotiation skills
- Strong focus on quality and attention to detail
- Knowledge in regulatories activitiy
- Motivated, self-starter with customer service and team orientation
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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