Senior Specialist Engineering - Pharmaceuticals Job - Netherlands
- For our Global Technical Operations (GTO) EMEA organization we are currently hiring a Senior Specialist Engineering - Pharmaceuticals
- Reporting into a Director GTO Pharm EMEA, the Senior Specialist Engineering will be responsible for leading the technical interface with external partners at the Tier 2 level.
- You will be a member of the GTO Pharm EMEA organization. This role acts as the technical interface between Merck and assigned external partners in the EMEA region.
- These partners may be Contract Manufacturing Organizations in the External Manufacturing space or regional manufacturing partners or licencees in the Global Supply Business Development space. Global Technical Operations is an integral part of the end-to-end Global Pharmaceuticals Operating Unit in the companies Manufacturing Division.
- You will provide technical leadership and oversight in the areas of technology transfer, validation, process support, deviation resolution, change control, process optimization, root-cause analysis, technical capability and due diligence assessments for assigned partners.
- As such this role is the technical point of contact for the partner and collaborates with other Merck functions (Quality, Operations, Supply Chain) and specialist COE’s in the Science & Technology network where needed.
- You will be responsible for project planning and executing technical transfer of pharmaceutical manufacturing processes to support commercial supply from an external partner, Joint Venture and other scenarios.
- Responsibilities will include acting as the technical interface with external partners in the area of compliant manufacture, process support to aid in the resolution of production issues that could impact supply and also to provide guidance on process optimization.
Your scope of work includes:
- Technology transfers, Investigations, Process Improvements, and Change Control;
- Assurance of complaint manufacturing process execution.
- Technical support and resolution on quality issues such as Deviations and Product Release;
- Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining the external partners assigned in the EMEA region;
- Responsibility for the technical aspects of fact finding around quality and supply investigations;
- Project accountability to execute Technology Transfer and on-going process; support and highlighting the need for the leveraging of shared resources from the Science and Technology network;
- Together with the Tier 2 team (Ops Q, tech), establishing a calibrated technical oversight approach based on the product type as well as the capabilities and technical competence of an external partner;
- Together with the Tier 2 team (Ops, Q, tech), establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with external partners in the region;
- Providing technical expert consultation and review on commercial agreements;
- Assignment to participate in Technical due diligence assessments;
- Assuring technical site readiness for all new product introductions or transfers;
- Participating in periodic Business and Relationship Review Meetings (as appropriate) with partners.
- Travel will be associated with this position at approximately 25%-50% largely in the EMEA region.
- University honors degree in engineering, chemistry or pharmacy;
- At least 5 years of hands on manufacturing experience in the areas of process start up and technical transfer or demonstrated experience in pharmaceutical and packaging operations in general and solid dosage in particular, including quality systems and process technology;
- Minimum green belt level, black belt preferred;
- Demonstrated deep technical skills in the areas of solid dosage, liquid, creams and packaging operations.
- Additional high level understanding of the areas of sterile manufacturing and microbiology;
- In depth understanding and proven expertise in application of GMP’s, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification;
- Advanced understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex task;
- Strong quality, compliance and safety mindset.
- Strong analytical skills and decision making skills;
- Strong project planning and management skills;
- Strong team player and collaboration skills;
- Strong communication skills and flexibility in communicating with partners that are either not fluent in English and/or lack IT infrastructure.
- Strong oral and written communication skills in in English and at least one other EMEA spoken language.
- Our company 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.
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.
Job Segment: Microbiology, Pharmaceutical, Engineer, Pharmacy, Business Development, Science, Engineering, Healthcare, Sales