Projects Associate Director Job

Date: May 9, 2019

Location: Carlow, IE

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Requisition ID: PRO018991

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


& SPECIFIC OBJECTIVES 


This role is to lead and manage multiple Engineering projects needed to support the business at Carlow. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration

POSITION RESPONSIBILITIES 


Manage projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow
Use scientific, product and process understanding as a basis for developing risk based approaches to investigations and trouble shooting that will feed into future projects.

Develop project scope, cost and delivery time schedule for all Engineering projects, working and collaborating closely with Technical engineering leads and Operational leads to ensure integration into ongoing Validations and/or Technical transfers.
Collaborating closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site.

Act as a subject matter expert on: equipment design and qualification; assisting in 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, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.

Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).

Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.


Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects

Lead and assist in the development and coaching of Technical Engineering personnel whilst delivering to the site business needs.

Drive collaboration between groups proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.

Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.

Required to comply with MSD Global Policies, Procedures and Guidelines,
regulatory requirements and execute current Good manufacturing Practices (cGMP) in the
performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.

Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (egg. MSD network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering Carlow at Global Technical Forums as required.

May be required to perform other duties as assigned.
Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS 

General
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects.
  • Experience in leading through change would be an advantage.


Technical
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processingenvironment
  • Good shipping/Filter/Cleaning validation knowledge required
  • Knowledge of QbD/CPV desirable
  • Excellent report, standards, policy writing skills required
  • Recruitment and selection experience
  • Automation and MES knowledge
  • Proficiency in Microsoft Office and job related computer applications required
  • Lean Six Sigma Methodology experience desired
  • Experience in audit preparation and execution desired
  • Having a strong safety ethos
  • Have proven record of process improvement implementation
  • Have a proven record of project management of change in a commercial site

People
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects.
  • Experience in leading through change would be an advantage.

Education
  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Green Belt preferable

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.


Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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