For Pharmaceutical Operations Integrated Process Teams (IPT’s) and Centers of Expertise (CoE’s) in Oss we are recruiting for several roles of:
Compliance Engineer - Pharmaceutical Operations
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
MSD. Be well. For more information, visit our website: www.werkenbijmsd.nl
Reporting into the IPT Lead / CoE Lead (and a functional reporting line to the local EHS department) the Compliance Engineer ensures compliance to external and internal EHS regulations /EHS standards and guidelines. You will be responsible for maintaining & improving the EHS Management System within the IPT / CoE and where applicable will support sharing of systems and tools across departmental boundaries. You will be responsible for guiding internal and external inspections/ audits and will continuously analyze current performance to find and lead improvements. You will have no direct reports.
Other tasks and responsibilities:
- Translating new regulations and corporate requirements (gap analysis) to IPT / CoE implementation plans;
- Supporting implementation of strategy in the operational organization;
- Acting as 1st contact person to global EHS organization on site.
- Supporting IPT / CoE in developing & performing operational compliance tasks (EHS) and improvement projects;
- Managing overview of (new) compliance improvement projects (global) and new policies and assuring timely execution via TIER4 priority setting;
- Monitoring actual operational EHS compliance within IPT’s and taking action if required (go to Gemba);
- Ensuring working according to guidelines; undertaking immediate actions to solve issues (Act Now);
- Advising IPT Lead / CoE Lead in case of non-compliances;
- Developing and reporting compliance related KPI's (incl. deviations, incidents / CAPA’s etc.);
- 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;
- Participating in EHS local, regional and global improvement / implementation projects;
- Being change owner for compliance (non-processes) related changes;
- Supporting improvement engineers with EHS knowledge and the implementation of changes / improvements.
- Preparing and coordinating all necessary activities required for internal (incl.
global) and external compliance inspections /audits;
- Representing department during inspections;
- Ensuring that observations found during inspections are reported timely solved (action plans) and closed.
- Ensuring that new regulations/ guidelines (EHS) are effectively communicated and trained to all IPT/CoE members. Support establishing annual EHS training plans.
- Coordinating, performing and ensure actual RIE's in IPT / CE
- Performing root cause investigations of small incidents and unsafe situations within IPT/COE;
- Performing Task Risk Analysis; supporting line management by high risk work activities and work permits;
- Participating in investigation teams in case of major incidents;
- EHS Expert within IPT / CoE, safe work procedures, corporate guidelines and regulations;
- Being consulted for changes in processes, equipment and investment projects (EHS assessments);
- Ensuring compliance to Environmental Permit requirements;
- Authoring for EHS WI / Manuals.
- Bachelor’s or Master’s degree in Chemical Engineering or equivalent technical field;
- Additional education in HVK (Hogere Veiligheidskunde), IH (Industrial Hygiene), MoSHE (Management of Safety, Health & Environment) or Bio Medical science;
- At least 3 years of experience in EHS and/or operational role;
- Willingness to certify as an EHS professional;
- Knowledge of GMP, ISPE, ISO, and FDA (Lean 6-sigma experience/ belt certificate is preferred);
- Open for change and passion for Lean and Continuous Improvement;
- Ability to influence and communicate with all levels of the organisation (from shop floor to senior management);
- Strong advisory skills and helicopter view over multiple IPT’s/ CoE’s;
- Strong oral and written communication skills in both Dutch and English
A good place to work
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
For more information about the position, please contact Johan Vreugdenhil, Associate Director, Safety & Environment: 0412-666408.
If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.
Op deze vacature is een wervingsbonus (referral) van toepassing voor MSD medewerkers
Job: Env, Health & Safety Generic Job Title:Spclst, Safety & Environment
Primary Location: EMEA-Netherlands-NB-Oss
Employee Status: Regular
Number of Openings: 5
Company Trade Name:MSD
Job Segment: Compliance, Engineer, Medical, Pharmaceutical, CAPA, Legal, Engineering, Healthcare, Science, Management