Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. Drug discovery solutions are provided in form of fee-for-service work, integrated drug discovery alliances, development partnerships, licensing of innovative drug candidates and consulting arrangements. The Company operates worldwide and has leading scientific experts, state-of-the-art technologies as well as key therapeutic expertise in the areas of neuroscience, diabetes and complications of diabetes, pain and inflammation, oncology and infectious diseases. By leveraging this expertise, Evotec intends to develop best-in-class and first-in-class differentiated therapeutics on its systematic, unbiased and comprehensive infrastructure.
Evotec has long-term discovery alliances with partners including Bayer, CHDI, Sanofi, Genentech, Janssen Pharmaceuticals and UCB. In addition, the Company has existing development partnerships and product candidates both in clinical and pre-clinical development. These include partnerships e.g. with e.g. Janssen Pharmaceuticals in the field of Alzheimer’s disease, with Sanofi in the field of diabetes and with Pfizer in the field of tissue fibrosis.
Evotec is built on integrated drug discovery know-how of over 20 years and is a leading player in the drug discovery field. The Company’s headquarters are located in Hamburg, Germany. Additional major operating sites exist in Abingdon and Manchester, UK; Göttingen and Munich, Germany, South San Francisco, Branford and Princeton, USA as well as Toulouse, France. Evotec has approx. 1,000 employees worldwide.
Responsible for the day-to-day operation and maintenance of the equipment and utilities supporting a cGMP biologic manufacturing operation. This position has overall responsibility for the process equipment, Water-For-Injection (WFI) system, chillers, boilers, water treatment, air handling, autoclaves, clean compressed air and process gases, and other support areas.
Develop and implement a facility management program including preventative maintenance, spare parts inventory, and life-cycle requirements
Respond to and document facility and equipment alarms and system failures
Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures and manufacturing documentation.
Conduct and document regular inspections, maintenance and calibration of facilities and equipment
Coordinate and document metrology activities for utilities, process equipment, and lab equipment.
Provide prompt response to requests and issues from Manufacturing and Quality
Plan and manage facility services such as janitorial, GMP gowning supply, and waste disposal
Provide support for ergonomics, business continuity and EH&S functions
Manage and review service contracts to ensure facility management needs are being met
Generate and present regular reports and reviews of facility-related budgets, finances, contracts, expenditures and purchases
Qualifications and Education Requirements:
Bachelor’s degree in Facilities Management, Facilities Engineering or related qualification
5+ 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
Experience with change control and validation related to GMP utilities and equipment
Practical knowledge of eQMS, automation (DeltaV), and QBMS/BMS systems
Working knowledge of electrical and mechanical systems
Working knowledge of procurement and contracts
Knowledge of health, safety, and environmental regulations
Experience in construction, 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
Motivated, self-starter with customer service and team orientation
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 studies, with equal competences, all the applications including people with disabilities.
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