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Merck & Co, Inc

Associate Director- Commissioning & Qualification, Global Engineering Solutions ( MERCUSR114238ENUS)

Engineering and Architecture

Architectural Director

Yearly

No

Durham, North Carolina, United States

Job Description

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.

Position Description:

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

Position Qualifications:

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.

INVENT.

IMPACT.

INSPIRE.

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.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

50%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R114238