Director, Durham Validation Leader

Job Description Our Engineers support internal and external manufacturing operations to build, develop, operate, and 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: Responsibility and Primary Activities The Durham Validation Leader role provides sustaining support to manufacturing operations across all IPTs, by leading the site Validation Center of Excellence.- The primary responsibility is to lead the team of validation Subject Matter Experts as part of the site Technical Operations team supporting vaccine manufacturing operations spanning drug substance and drug product areas.- Expected outcomes include:

• Defining and maintaining validation strategy for the overall site and each manufacturing area
  
• Proactively maintaining a strong state of compliance with all validation requirements
  
• Defining and maintaining metrics to streamline communication of organization performance
  
• Maintaining strong connections to other MMD sites, global functions, centers of excellence and communities of practice
  
• Increasing awareness of evolving industry and compliance standards to support external influence and to capture best/next practices
  
• Providing technical guidance to staff, colleagues, and customers
  
• Ownership of site validation SOPs, protocol/report templates, training curricula, etc.
  
• Maintaining a state of permanent inspection readiness for the site validation organization in preparation for health authority inspections
  
• Defending site and company validation approaches to health authorities during inspections and supporting responses as needed
  
• Maintaining an effective contract staffing model as needed
  
• Developing the next generation of validation and technical leaders
  
• Driving continuous improvement in validation approaches and performance to deliver better cost, yield and compliance outcomes.
  

The Durham Validation Leader will report to the Durham site Technical Operations Leader.- The Durham Validation Leader will align with the Durham site Technical Operations leader, and as needed with site and global operations, global CoE's, technical operations, digital/IT, engineering and EHS leaders to deliver functional excellence and standard approaches.- The Durham Validation Leader is a member of the site Technical Operations leadership team, and will typically lead a department of ~50 personnel.- This leader is responsible for ensuring the required competencies, talent management and development of their people. This leader will create the environment in the group for collaboration across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a boundary-less organization mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in knowledge management, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing in the flow of the core work. Core Technical Functional Competencies Technical Expertise in a variety of validation disciplines (cleaning, sterilization, equipment qualification, etc).- Demonstrated competence in live virus vaccines, sterile/aseptic processing, lyophilization, fermentation, and purification with a demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results. Professional Competencies Business Acumen and Financial Management

• In-depth knowledge of financial systems (budgets, expenses, product standards and variances.)
  
• Creates awareness of cost levers from Tier 5 to Tier 1, driving productivity at all levels.
  

Problem Solving

• Gathers and analyzes data and effectively responds to new, complex, or problematic situations; creates solutions that drive value for Our Company and our customers, incorporating innovative approaches.
  
• Leverages Our Company's Production System (MPS) or equivalent tools, eg 8 step problem solving.
  
• Models and teaches scientific problem solving approaches to group and peers.
  
• Demonstrates a lean mindset and drives continuous improvement
  

Project Management

• Organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery and right first time by integrating with partner areas.
  

Strategic Thinking and Working across Boundaries

• Thinks and acts beyond one's silo
  
• Bridges boundaries across teams, functions, divisions, geographies, external stakeholders, and customers.
  
• Practices and sponsors Inclusive Behaviors and mindsets in the flow of work.
  
• Models behaviors consistent with a Boundary less Organization mindset - Right People, Place, and Time.
  

Productive Communication

• Plans and delivers ideas and information to others in a clear and impactful manner.
  
• Continuously communicates to align with partners and stakeholders
  
• Communicates effectively with direct reports and employees.
  

Leadership & Managerial Drive Results:

• Sets clear performance standards including stretch goals for self and workgroup
  
• Overcomes obstacles
  
• Holds self and others accountable for achieving results
  
• Works proactively to remove barriers to achieving and exceeding goals.
  
• Communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders.
  

Build Talent:

• Utilizes standard performance management and talent management processes.
  
• Build diverse talent within the workgroup with the capabilities necessary for future success.
  
• Continuously assess competencies versus future needs and plan to fill gaps.
  
• Reward and develop employees to ensure individuals reach their full potential.
  

People Management

• Is an experienced Coach and teacher of people.
  
• Demonstrated application of culture and business change methodologies (eg Change Execution Methodology, Inclusive behaviors, etc) when realizing site and cross functional process improvement initiatives.- -
  
• Demonstrates Inclusion and Leadership behaviors, including integrity, resilience and flexibility.
  
• Ensures team members have the skills and capabilities to do their jobs.
  
• Maintains and develops empowerment.
  
• Ensures regular team communications using the Tier Process.
  
• Oversees conflict resolution
  
• Oversees and carries out Performance Management, Talent Management activities, including employee development plans.
  

Required Education, Experience and Skills:-

• Bachelor's degree in Engineering, Science, or related field AND at least ten (10) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR
  
• A Master's Degree AND at least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR
  
• A Doctorate degree AND at least five (5) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry
  
• Experience managing a team, including coaching and developing people
  
• Technical expertise in a variety of validation disciplines (cleaning, sterilization, equipment qualification, etc)
  
• Demonstrated competence in live virus vaccines, sterile/aseptic processing, lyophilization, fermentation, and purification with a demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results.
  

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time. 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. 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. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. 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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. - For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• Pay Transparency Nondiscrimination 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. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Domestic/International VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Not Applicable Shift:
1st - Day Valid Driving License:
No Hazardous Material(s): Job Posting End Date:
06/21/2024
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date: 06/21/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R299144