Senior Process Engineer – Tech Transfer Job

Date: Jul 12, 2019

Location: Carlow, IE

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Requisition ID: MAN006653

Senior Process Engineer – Tech Transfer (MSDC)

MSD CARLOW


Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

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.

INTRODUCTION 

At MSD Ireland, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

THE COMPANY 

MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.
We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses. 
In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.
With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.

MSD CARLOW

MSD in Carlow is a world-class manufacturing facility, and the company’s first stand-alone vaccine and biologics facility outside the US. Carlow employs over 350 highly skilled employees and is an important element of MSD’s network of sites, playing a pivotal role in the manufacture of our immuno-oncology treatment.
MSD Carlow is a state-of-the-art, 200,000 sq ft vaccines and biologics facility focused on formulating and filling vaccine and biologic products that improve and transform the lives of people across the world. 

MSD’s sustained investment in Ireland empowers Carlow to offer its team the opportunity to continuously grow, learn, invent and thrive. 

We are growing our highly-skilled team and building our presence in Carlow so that we can continue to lead scientific breakthroughs in the treatment of some of the world’s most harmful diseases.

& SPECIFIC OBJECTIVES 

  • This Technical Engineering role, will play a key part in the development of MSDC Carlow Drug product facility
  • This role is to lead and participate in activities to deliver on the Tech Engineering requirements needed to support the business at Carlow. This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration
  • The Technical Engineering role will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable MSD standards for Quality and EHS compliance

POSITION RESPONSIBILITIES:

Safety
  • Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (eg., 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

Compliance
  • Required to comply with 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
  • Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance

Process Engineering & Validation

  • To lead and execute process engineering and validation activities to support the technical transfers as well as sustaining site validation activities such as reQualifications, annual reviews etc This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation

Projects
  • To lead and manage multiple Technical 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

Continuous Improvement
  • To manage and deliver on all technical/Validation/Quality Notifcations/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk based approaches to investigations and trouble shooting
  • Drive collaboration between group functions and proactively looking for synergies and innovative ways of doing work

Technical Expertise
  • Act as a subject matter expert on (1) Equipment Design & qualification; (2) Assisting in C&Q execution and planning; (3) Process design and validation
  • Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects


QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

Why is this a compelling position for a dynamic and ambitious leader in Biopharma to consider?

  • This is a hugely exciting opportunity for an ambitious and experienced individual to play a key role in a dynamic, motivated, high-performing group at an exciting moment for MSD’s expansion in Ireland. 
  • The role is a chance to shape the development of a state-of-the-art facility and holds future opportunities for advancement. 
  • The candidate will be actively supported and encouraged to continue their professional development 

REPORTING STRUCTURE

Technical Engineering Lead
Qualifications

  • 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.
  • Experience with facility commissioning and startup an advantage
  • A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment
  • Knowledge of and experience in applying Six Sigma and Lean methodologies

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 processing 
  • Experience of executing and/or managing through equipment and process validation in a sterile environment
  • Knowledge of QbD/CPV desirable
  • Automation and MES knowledge
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost

People
  • The passion to expand the future of Carlow
  • A great communicator, decisive decision-maker with a proven ability to deliver excellence
  • Willingness to support the team and a strong focus on delivering excellence.
  • Engage with our business colleagues and learn from them as well as from our own experiences
  • Vendor liaison
  • Effective time management and multi-tasking skills
  • Excellent attention to detail
  • Strong change management skills

Education
  • Degree qualification or equivalent (Science, Engineering, Technical)
  • 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.

Search Firm Representatives Please Read Carefully: 
MSD is not accepting unsolicited assistance from search firms 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: Manufacturing Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Process Engineer, Medical, Oncology, Manufacturing Engineer, Engineer, Engineering, Healthcare

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