Compliance Engineer EHS Warehousing &Facilities - Netherlands
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- Over 1500 employees work in the pharmaceutical, chemical and biotechnological production in our company
- Within our company, novel biologic active ingredients (“Drug Substance”) are manufactured, including medicines for fertility, diabetes, and oncology.
- We have global partners in the U.S., Europe and Asia Pacific to ensure medicines are delivered in a safe, reliable and cost-effective way.
- The Supply Chain Management department consists of approximately 27 FTE.
- The Manufacturing Support Center is part of the Supply Chain Management department and the other supporting facilities of the Facilities & Engineering department
- Reporting into the Supply Chain Management Lead, the Compliance Engineer EHS will be responsible for ensuring compliance to internal and external EHS guidelines and regulations.
- You will be working closely together with the Manufacturing Support Center personnel, Facility & Engineering department, EHS Center of Excellence and external service providers.
- You will be responsible for maintaining and managing EHS processes within the Site and various Partners. You will also be responsible for leading improvement projects.
- Working as a Compliance Engineer, you will be responsible for:
- Ensuring a strong EHS compliance level of the facilities and service partners resulting in Permanent Inspection Readiness;
- Performing risk assessments; supporting line management & contract personnel by high risk work activities;
- Acting as SME during risk assessment like HAZOPs, FMEA, RIE and root cause analysis.
- Leading incident and near miss investigations, reporting in the Global EHS administrative systems, developing CAPAs where required and tracking actions until completion.
- Evaluating effectiveness of established CAPAs;
- Being consulted for changes in processes, equipment and investment projects (management of change);
- Ensuring compliance to work permit system (werkvergunningen system);
- Ensuring compliance to (Environmental) Permit;
- Maintaining and improving the processes and related procedures to comply to the latest EHS standards. This included writing & improving of various SOP’s and instructions;
- Ensuring that new regulations/ guidelines (EHS) are effectively communicated and trained to all relevant personnel. Support establishing annual EHS training plans;
- Coaching and teaching personnel on the shop-floor to obtain the right mindset and (improvement) culture;
- Monitoring of actual operational EHS compliance by Key Performance Indicators and initiating actions;
- Managing observations and/ or events and related communication. Developing corrective and preventive actions;
- Actively closing potential GAP’s with local or global guidelines by taking ownership of issues;
- Preparing and guiding internal and external inspections and audits;
- Solving potential observations from audits;
- Connecting to other EHS experts within the site or other company sites to harmonize & improve way of working.
- Maintaining or implementing a site-broad EHS standard.
- Bachelor’s or Master’s degree in Technology or EHS related discipline, with willingness to complete the appropriate EHS education (e.g. HVK Hogere Veiligheidskunde, IH (Industrial Hygiene);
- At least 3 years of EHS experience in highly regulated warehouse, commercial production or (industrial) service organization;
- Knowledge of GMP,ISPE, ISO and FDA;
- At least 3 years of relevant experience in a biotech, pharmaceutical, chemical manufacturing or food operations environment;
- Demonstrated ability to manage projects;
- Pro-active attitude with an improvement mindset and strong analytical skills;
- Ability to influence and communicate with all levels of the organization from shop floor to senior management;
- Leads by example and must have excellent communication skills with shop-floor personnel.
- Excellent communication skills in Dutch and English.
- Experience with PGS15, ADR regulation;
- Experience with Risk assessments, HAZOP’s;
- Experience with support of regulatory and corporate audits;
- Experience with Six Sigma and/ or Lean principles, yellow or green belt certification;
- Experience with contract management;
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