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Associate Director Commissioning & Qualification

Posted 26 Mar 2024
Work experience
2 to 5 years
Full-time / part-time
Full-time
Degree level
Required language
English (Fluent)

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Associate Director Commissioning & Qualification

Boxmeer

Fulltime

We have an exciting new opportunity for an

Associate Director Commissioning & Qualification

Purpose of the role

The Associate Director functions under the guidance of the C&Q Leader within Global Engineering Solutions (GES) and works with our Engineering Partners to ensure individual projects have appropriate C&Q leadership during design and execution. This position will provide direct project support for projects as identified by the Technology Center and Area Delivery Directors including hyper-care support for strategic or at risk projects.

The Associate Director exhibits strong leadership, interpersonal and communication skills, decision making and the ability to guide global work. The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations. Flexibility with global travel as needed to support current project’s is also required.

The Associate Director will contribute to the development and maintenance of core documents such as internal Practices, Procedures, Design Guides and Engineering Standards. In addition, they should participate in professional/technical organizations and in the development and delivery of subject matter training for GES.

Primary responsibilities

  • Work with Process Design Managers in the development of Regulatory Design Basis and C&Q Execution Strategy during Concept and Basis of Design phases of projects.
  • Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully execute projects.
  • Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Product Quality Risk Assessments
  • Provide direct project support for strategic and at risk projects to ensure successful execution of the C&Q strategy.
  • Participate in project assessments for active projects to identify opportunities for improvement and confirm readiness for project to progress through the stagegate process.
  • Acts as a subject matter expert on: regulatory compliance in facility and equipment design and qualification; C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. and requirements traceability matrices, Construction QA/QC, Turnover Pack compilation, Document Mgt. Systems, FAT/SAT and C&Q protocol development.
  • Support the implementation of GES standard work across all sites.
  • Participate in the implementation of digital/paperless C&Q execution.
  • Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into the C&Q value stream.
  • Facilitate C&Q peer reviews across projects to mitigate against unintended omissions/gaps in strategy and execution plans.
  • Through use of leading indicator/KPI’s and regular assessments of critical to C&Q project deliverable progress, ensure right first time delivery for the C&Q phase.
  • Ensure adherence to Quality Manual guidelines & GES Practices and Procedures.

Your profile

  • Bachelor’s Degree in Chemical/Mechanical Engineering, Biotechnology or equivalent applied life sciences qualifications.
  • Strong interpersonal and communication skills, decision making and the ability to guide work teams in the region.
  • The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
  • Extensive C&Q experience, including a C&Q leadership role on a significant large capital project in the Pharmaceutical / Biotech Industry
  • Experience in Drug Substance, Drug Product and Labelling & Packaging as well as clean and black utility systems
  • Experience staffing and managing contract personnel on a project team basis
  • Demonstrated knowledge of ISPE Baseline Guide 5; ASTM E-2500; FDA, EU regulatory requirements
  • Excellent analytical abilities and a solid base in engineering fundamentals
  • Demonstrated leadership, teamwork and interpersonal skills
  • Proven written and verbal communication skills – English – as the platform language for communication in science and engineering
  • Ability to foster strong collaborative working relationships with internal colleagues and customers, and external partner resources in a culturally diverse environment
  • Teaching, training and coaching of internal colleagues and partner resources
  • Dynamic ability to work across a portfolio of projects;
  • Change management - sponsor an end to end mindset – successful capital project delivery is a key enabler to a successful start-up in realizing on-time, reliable and compliant product supply
  • Passion for instilling a proactive safety, environmental and regulatory compliance culture

Experience in the following areas is preferred:

  • Post-OQ/Tech Transfer phase – Clean Utility, HVAC/environmental and Process PQ’s; cleaning, thermal cycle development and validation; demonstration batch manufacture; operational readiness and maintenance readiness workstreams
  • Familiar with our organizations Procedures and Guidelines
  • Experience with digital/paperless validation
  • Prior project management knowledge
  • ISPE GAMP 5 – Risk Based approach to compliant GxP Computer Systems
  • Lean/Six sigma belt certification/experience

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

  • Competitive salary;
  • Annual Incentive plan
  • Attractive collective health care insurance package with considerable reduction rates;
  • Solid Pension Plan;
  • Numerous training, coaching and e-learning modules for long term job opportunities and development

MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de…


MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de diepte, door je te specialiseren in je vak. Maar ook door jezelf te verbreden en door te groeien naar een leidinggevende functie. Internationaal of juist heel lokaal, er zijn talloze andere mogelijkheden om stappen te zetten in je loopbaan, te rouleren in functies of te groeien in je functie. Werken bij MSD is werken in een dynamische high tech omgeving van internationale allure, die toch sterk lokaal geworteld is in Oss, Haarlem en Boxmeer.

Pharmaceutical
Haarlem
5,600 employees