Senior Specialist Engineering - Pharmaceuticals Job

Date: May 30, 2019

Location: Oss, NB, NL

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Requisition ID: PRO019434


For our Pharmaceutical Technical Operations (PTO) External Manufacturing EMEA region organization we intend to hire a: 





Senior Specialist  Engineering - Pharmaceuticals

This role is based in Europe at an MSD manufacturing site (Oss, Cramlington, Haarlem, Heist, Ballydine, Brinny) or MSD office (Dublin, Lucerne, Madrid); working from home is also allowed.






The position
Reporting into the Director PTO 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 (Global Technical Operations) Pharm EMEA organization. This role acts as the technical interface between MSD and assigned external partners in the EMEA region. These partners may be Contract Manufacturing Organizations in the External Manufacturing space or regional manufacturing partners. 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 MSD functions (Quality, Operations, Supply Chain) and specialist CoEs 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.  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;
• Qualification of packaging lines also including serialization implications;
• 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.





Location
This position is based in Europe at an MSD manufacturing site (Oss, Cramlington, Haarlem, Heist, Ballydine, Brinny) or MSD office (Dublin, Lucerne, Madrid), but working from home is an option as well.





Travelling
Travel will be associated with this position at approximately 20%-40% largely in the EMEA region.

 
Qualifications


• University 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, and packaging operations are strongly preferred.
• 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 teamplayer 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.





Inormation

For more information about this role you can contact Lucio Albertin, Director Engineering, PTO-Ex Mfg EMEA, by phone:+ 39 331 6703658





Application
If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.


Job: Process Engineering
Other Locations: Madrid, Comunidad DE Madrid, ES; Cramlington, England, GB; Heist op den Berg, Van, BE; Luzern, Lucerne, CH; Brinny, Munster, IE; Tipperary, Munster, IE; Dublin, Leinster, IE; Haarlem, North Holland, NL
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Engineer, Pharmacy, Supply, Pharmaceutical, Process Engineer, Engineering, Healthcare, Operations, Science

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