Associate Director, Automation - Hybrid

Job Description

Our Company is expanding its global recombinant vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.

Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

Position Responsibilities:

The Associate Director Manufacturing Automation is responsible for managing the team in Durham, NC facility for the assigned area process control systems, while actively supporting an inclusive team culture.

Responsibilities may include but are not limited to:

• Directing the technical activities of a professional staff to achieve facility business objectives with on the production shop floor support as needed.
• Providing technical leadership for the assigned area and systems to ensure a compliant and reliable supply of product and on time project execution.
• Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert.
• Leading individual and team development through approved HR guidance and practices, while maintaining staffing at the agreed upon level any by actively engaging in efforts to recruit talent that supports a diverse and inclusive culture.
• Providing guidance on system activities to the Integrated Process Team (IPT) leadership team with overall accountability for team and system performance within area of responsibility.
• Providing guidance and ensuring that the team follow established standards, principles and governance.
• Providing technical guidance/support for key review and approval of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, and other key automation related processes.
• Assisting in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities.
• Supporting problem solving practices to identify and resolve technical and operational problems; able to collaborate with peers to resolve problems that cross into inter-related units.
• Adapting and implementing area plans and priorities based on IPT scorecard to address local business challenges.
• Other duties requested by Management.

Working Relationships:

• Reports to the Director Manufacturing Automation.
• Manages and interacts with employees within own department.
• Frequent interaction with employees from other departments.
• Interacts with representatives from regulatory agencies and external suppliers.

Education Minimum Requirement:

• Bachelor's Degree or higher in Engineering, Computer Science, or related Technical area.

Required Experience and Skills:

• Minimum eight (8) years of experience in a production regulated industry (part or all of the eight years providing manufacturing automation services) - OR - Master's or MBA degree with six (6) years' experience - OR - PhD with three (3) years' experience.
• Two or more years of direct people management experience.
• Minimum of five (5) years of experience in a GMP manufacturing automation related role and direct experience with SDLC and change controls.
• Direct experience with at least two of the three platforms 1) Process Automation (DeltaV), 2) PLCs, and 3) PI/InfoBatch (or equivalent).
• Demonstrated ability to build relationships with team, peers and area leads.
• Demonstrated leadership in achieving shared objectives in a matrix organization.
• Strong understanding of manufacturing principles/ processes and ability to translate manufacturing requirements into Automation/digital solution.
• Proven track record of analytical skills, problem solving and attention to detail.
• Able to demonstrate the Company Leadership Principles and Enterprise Leadership.
• High personal integrity, credibility, and energy.
• Excellent communication and influencing skills.
• Strong written and verbal communication skills in English.

Preferred Experience and Skills:

• Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working knowledge of S88.
• Lean Six Sigma Experience.

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:

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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.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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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

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Requisition ID:R252632