Are you ready to Invent, Impact, Inspire?
Join MSD and shape the future of healthcare in Ireland
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.
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 %242.5 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 Brinny is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world. With a team of approximately 500 people, MSD Brinny specialises in the late-stage development and commercial supply of biotech products, including some of the company's most successful and life-changing treatments for oncology, hepatitis C and rheumatoid arthritis.
The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers. MSD has invested €130m in the site since 2016 as a result of increased global demand for MSD medicines and vaccines which will see MSD Brinny further expand its production facilities and capacity to meet this demand.
JOB DESCRIPTION & SPECIFIC OBJECTIVES
The Senior Specialist functions under the guidance of the Associate Director C&Q EMEA within Global Engineering Solutions (GES) and works with our Engineering Partners to ensure individual projects have appropriate C&Q leadership during design and execution.
The position can be based at any of our European sites.
This position will provide direct project support for projects as identified by the Technology Center and Area Delivery Directors including hyper-care support for strategic or at risk projects. The Senior Specialist exhibits strong leadership, interpersonal and communication skills, decision making and the ability to guide global work. The candidate should have a solid understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations. Flexibility with travel as needed to support current proejcts is also required.
The Senior Specialist will contribute to the development and maintenance of core documents such as internal Practices, Procedures, Design Guides and Engineering Standards.
Primary responsibilities include, but are not limited to:
- Work with Process Design Managers in the development of C&Q Execution Strategy during Concept and Basis of Design phases of projects.
- Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully execute projects.
- Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Product Quality Risk Assessments
- Provide direct project support for strategic and at risk projects to ensure successful execution of the C&Q strategy.
- Participate in project assessments for active projects to identify opportunities for improvement and confirm readiness for project to progress through the stagegate process.
- Acts as a subject matter expert on: regulatory compliance in facility and equipment design and qualification; 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, Construction QA/QC, Turnover Pack compilation, Document Mgt. Systems, FAT/SAT and C&Q protocol development
- Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into the C&Q value stream
- Facilitate C&Q peer reviews across projects to mitigate against unintended omissions/gaps in strategy and execution plans
- Ensure adherence to Quality Manual guidelines & GES Practices and procedures
This position reports in to the regional C&Q Lead with the Engineering Compliance group of Global Engineering Solutions.
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
Required Experience and Skills: The Senior Specialist must exhibit strong interpersonal and communication skills, decision making and the ability to guide work teams in the region. The candidate should have a solid understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
- Significant C&Q experience, including a C&Q leadership role on mid-sized capital projects in the Pharmaceutical / Biotech Industry
- Experience in Drug Substance, Drug Product and Labelling & Packaging as well as clean and black utility systems
- Experience supervising contract personnel on a project team basis
- Demonstrated knowledge of IPSE Baseline Guide 5; ASTM E-2500; FDA, EU regulatory requirements
- Excellent analytical abilities and a solid base in engineering fundamentals
- Demonstrated leadership, teamwork and interpersonal skills
- Proven written and verbal communication skills – English – as the platform language for communication in science and engineering
- Ability to foster strong collaborative working relationships with internal colleagues and customers, and external partner resources in a culturally diverse environment
- Change management - sponsor an end to end mindset – successful capital project delivery is a key enabler to a successful start-up in realizing on-time, reliable and compliant product supply
- Passion for instilling a proactive safety, environmental and regulatory compliance culture
Preferred Experience and Skills: Knowledge/experience in the following areas is preferred:
- Post-OQ/Tech Transfer phase – Clean Utility, HVAC/environmental and Process PQ’s; cleaning, thermal cycle development and validation; demonstration batch manufacture; operational readiness and maintenance readiness workstreams
- Familiar with MSD Procedures and Guidelines
- Prior project management knowledge
- ISPE GAMP 5 – Risk Based approach to compliant GxP Computer Systems
- Lean/Six sigma belt certification/experience
- BS Degree in Chemical/Mechanical Engineering, Biotechnology or equivalent applied life sciences qualifications.
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.
So, if you are ready to:
INVENT solutions to meet unmet healthcare needs
IMPACT the future by joining MSD, one of the world’s leading healthcare companies
INSPIRE your team to reach their full potential and push the boundaries of science and technology
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 Title: EMEA-Ireland-Munster-Cork
Primary Location: EMEA-Netherlands-NB-Boxmeer, EMEA-Ireland-Munster-Tipperary, EMEA-Ireland-Leinster-Carlow, EMEA-Netherlands-NB-Oss
Employee Status: Yes, 25 % of the Time