Associate Director- Commissioning & Qualification, Global Engineering Solutions ( MERCUSR114238ENUS)
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
The Associate Director functions under the guidance of the C&Q director within Global Engineering Solutions (GES) and works with our Engineering Partners to ensure projects have appropriate C&Q leadership during design and execution. This position will provide direct project oversight for projects as identified by the Technology Center and Area Delivery Directors including hyper-care attention for strategic or at risk projects.
The Associate Director exhibits strong management and communication skills, decision-making and the ability to guide global work. The candidate should have a strong comprehension of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations. Flexibility with global travel as needed to assist current projects 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.
Assist 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 work with on the development of Project Validation Master Plans and execution of Product Quality Risk Assessments
Provide direct project assistance for strategic and at risk projects to ensure successful execution of the C&Q strategy.
Participate in project assessments to identify opportunities for improvement and confirm readiness for project to progress through the stage-gate 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
Assist in the implementation of GES standard work across all sites.
Participate in the implementation of digital/paperless C&Q execution.
Integration of Computer Systems Validation activities, in partnership 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 guiding 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
Required Education, Experience, & Qualifications:
BS Degree in Chemical/Mechanical Engineering, Biotechnology or equivalent applied life sciences qualifications.
The Associate Director must exhibit strong communication skills, decision making and the ability to guide work teams in the region.
The candidate should have a strong comprehension of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
Extensive C&Q experience, including a C&Q management 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
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 workstreams
Familiar with our Company Procedures and Guidelines
Experience with digital/paperless validation
Prior project management knowledge
ISPE GAMP 5 – Risk Based approach to compliant GxP Computer Systems
Lean/Six sigma belt certification/experience
Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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