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.
MSD Manufacturing Division, MMD, 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.
The Associate Director functions under the guidance of the Engineering Compliance Director within Global Engineering Solutions (GES) and works with our Engineering Partners to ensure individual projects have appropriate C&Q leadership during design and execution. This position will provide direct project support for strategic or at risk projects as identified by the Technology Center and Area Delivery Directors, including support of the the MSD Dublin Biotech Project.
The Associate Director exhibits strong leadership, interpersonal and communication skills, decision making and the ability to guide global work. The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations. Flexibility with global travel as needed to support current proejcts is also required.
The Associate Director will contribute to the development and maintenance of core documents such as internal Practices, Procedures, Design Guides and Engineering Standards. In addition, they should participate in professional/technical organizations and in the development and delivery of subject matter training for GES.
Primary responsibilities include, but are not limited to:
- Work with Process Design Managers in the development of Regulatory Design Basis and 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
- Through use of leading indicator/KPI’s and regular assessments of critical to C&Q project deliverable progress, ensure right first time delivery for the C&Q phase
- Ensure adherence to Quality Manual guidelines & GES Practices and Procedures
Education Minimum Requirement: BS Degree in Chemical/Mechanical Engineering, Biotechnology or equivalent applied life sciences qualifications.
Required Experience and Skills: The Associate Director must exhibit strong interpersonal and communication skills, decision making and the ability to guide work teams in the region. The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
- Extensive C&Q experience, including a C&Q leadership role on a significant large capital project in the Pharmaceutical / Biotech Industry
- Experience in Drug Substance, Drug Product and Labelling & Packaging as well as clean and black utility systems
- Experience staffing and managing 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
- Teaching, training and coaching of internal colleagues and partner resources
- Dynamic ability to work across a portfolio of projects;
- 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 work streams
- 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
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.
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