Associate Director – Engineering (Validation)
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.
To date, we have invested $2.5 billion in our Irish operations and 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.
Dublin, Ireland has been chosen for MSD’s first ever Large-Scale Mammalian-Based Drug Substance Facility. This facility will be a significant supplier of drug substance for one of MSD’s key treatments and will also be critical in the future supply of new biotechnology products to our global network.
Construction on this exciting new facility will commence immediately and this is a unique opportunity for the right person to shape, create, build and grow the MSD Biotech, Dublin site which will support the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology.
As one of the inaugural hires in project, the Associate Director - Validation role will be essential in ensuring efficient and effective compliant design, construction, qualification, approval and operation of the new state-of-the-art facility during the initial project phase. The successful candidate will take a lead on utilising the latest innovations in technology and automation to create a workplace of the future.
Reporting to the site manufacturing and technology head and based at the MSD Biotech Dublin site, the site Validation leader responsibilities include, but are not limited to the following:
- Provide oversight of the design, construction and qualification of the new MSD Biotech Dublin facility and manufacturing science and technology laboratory by:
o Providing technical and validation oversight to teams and coaching to associate staff. Provide leadership for:
Developing and maintaining the site Validation Master Plan.
Driving completion of cleaning and sterilization cycle validation activities.
Aligning the Process Performance Qualification (PPQ) strategy and delivering the necessary protocols and reports.
Building and maintaining the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
o Authoring and reviewing standard operating procedures and technical reports. Supporting global regulatory submissions as needed.
o Assuring effective application of LeanSixSigma and Change Management tools in the Validation group by:
Securing continuity of an appropriate LSS/CEM level of knowledge.
Leading by example in achieving results by using high performing organization (HPO) tools and processes
Facilitate problem solving & risk assessment (FMEA) projects/meeting.
Make problems visible and strive for continuous improvement.
o Serving as a key member during internal audits and external inspections/audits.
o Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
- Manage and coach a staff of 4-6 engineers.
- Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
- Keep up to date with scientific and technical developments.
- Support creation of departmental budget and surveil actual performance against the forecast.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
This role reports to the site manufacturing and technology head.
This role requires an experienced individual with a minimum of 6 years’ (for PhD), 10 years’ (for MSc) or 12 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within MSD.
Preferred Experience and Skills:
- Experience with upstream cell culture and downstream purification of biological molecules. Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
- Working knowledge of statistical process control (SPC) for biologics processes
So, if you are ready to:
INVENT solutions to meet unmet healthcare needs
IMPACT the future by driving MSD’s position as one of the world’s leading healthcare companies
INSPIRE your team to reach their full potential and push the boundaries of science and technology