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Job Description

GENERAL SUMMARY

The Engineering, Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations and provides the best in class services with the final goal of delivering our high-quality vaccines to the patients around the world

With our core principle of Safety First and Quality Always EMSS strives to have the safest and most compliant operation around the network.

EMSS has an Associate Director opening for the Vaccine Manufacturing Facility (VMF) Mechanical Services Engineering and Reliability Engineering team. The selected candidate will manage the engineering, maintenance and reliability activities related to the two Filling lines within this facility. The main equipment within these two Filling lines consist of Vial washers, Depyrogenation Tunnels, Fillers with Isolator technology, Lyophillizers, Visual Inspection Machines along with all the support equipment prep and clean utilities.

Strong technical and customer service-oriented leader to support the VMF IPT. Will lead the tactical and strategic equipment reliability improvements, human resources activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance.

The Associate Director of Engineering position will ensure the reliable performance of equipment by managing a team of Engineers in providing hands-on maintenance support for complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Associate Director of Engineering must be able to drive and demonstrate innovation, efficiency, and effective maintenance strategy to help achieve production targets and self-identify strategic opportunities for program improvement and execute with minimal supervision.

Responsibilities include leading a team of engineers to achieve the following:

+ Analyzing calibration, maintenance, and equipment performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability

+ Identification of revisions, deletions, or additions to the calibration and maintenance programs and Standard Operating Procedures (SOP’s) to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures

+ Working with the Operations, Technology, Automation, and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition

+ Helping establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities

+ Leading deviation investigations for instruments, equipment, and system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments

+ Leading in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency

+ Developing training material. Working as a subject matter expert (SME), providing necessary training for system maintenance

+ Working alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements

+ Supporting safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective

+ Collaborating with the production area maintenance technicians and management to maintain all production equipment

+ Collaborating with the Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area specific reliability actions

The associate director of Engineering will serve as the single point of contact and accountability for:

+ complex issue remediation and prevention

+ project and workload management/execution

+ risk quantification, escalation and mitigation

+ improving failure analysis/response

+ technician upskilling program improvement

The Associate Director serves to remove any roadblocks for the team to achieve success and ensures efficiency, effectiveness, leadership, optimization and standardization are at the fundamental core principles of every aspect of the VMF Mechanical Services Engineering team.

GENERAL PROFILE

+ Provides leadership and direction through individual and team contributions

+ Executes functional business plans and contributes to the development of group strategies

+ Priorities based on compliance, departmental budget and profit plan to address resource and operational challenges

+ Leverages relationships with key clients and/or customers to support business needs

PEOPLE MANAGEMENT

+ Coaches/mentors direct reports responsible for their area within Engineering, Maintenance & Calibration

+ Ensure proper team capabilities with appropriate trainings

+ Manage the area succession plan

FINANCIAL MANAGEMENT

+ Manage the VMF Maintenance cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year

PROJECT MANAGEMENT

+ Responsible for major equipment related projects, including funding, change control and equipment qualification within their area

+ Responsible for obtaining bids, reviewing contracts, supervising, and providing follows-up on contract work including the auditing of time and material reports for their area

SHUTDOWN MANAGEMENT

+ Responsible for assisting with master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdowns

+ Coordinates activities with stakeholders and project owners

+ Attends shutdown meetings ensuring activities are tracked and completed

PRODUCTION EQUIPMENT SUPPORT

+ Responsible for the preventive maintenance and calibration programs of all production equipment.

+ Daily support of all production equipment to ensure area safety, compliance, production and financial goals are met

+ Spare parts risk-based assessments and identification of new parts to replace obsolescent parts to ensure correct type and number of spare parts are available for all production equipment.

+ Establishes processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities

+ Manages equipment location and status in SAP as well as related equipment drawings.

+ Assists in deviation investigations for maintenance instruments, equipment, and systems.

+ Collaborates/Executes with the reliability engineers periodic RBAM assessments and owns area specific reliability actions

+ Collaborates with Automation for maintenance and troubleshooting equipment

+ Collaborates with equipment vendors

+ Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders with an emphasis on reducing reactive work and increasing reliability.

+ Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.

+ Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures.

+ Monitor KPIs (MTTR, MTBF, Uptime) and ensure its accuracy

WORKING RELATIONSHIPS

+ Reports to Engineering and Maintenance Director

+ Manages and interacts with employees within own department

+ Frequent interaction with employees from other departments

+ Interacts with representatives from regulatory agencies

+ Interacts with external suppliers

This position is a 1st shift position with the potential for occasional off-shift work as needed to support business results. This position is expected to work as both an independent member of an integrated team and in a leadership capacity focused on driving the team achievement of objectives, vision, and goals

Education:

+ Bachelor’s Degree or higher in Engineering, Science or related field

Required:

+ Minimum 8 years of progressive Maintenance and/or Engineering experience in regulated manufacturing environment (6 Years with a master’s degree or MBA: 3 years with a PhD)

+ Strong planning, scheduling, and time management skills

+ Working knowledge of regulatory requirements in accordance with GMP manufacturing operations

+ Good oral and written communication skills

+ Experience with GMP compliant calibration and maintenance databases

+ Project management experience including change control and equipment qualification

Preferred:

+ 10+ Years of cGMP experience in a sterile, bulk or finished pharmaceutical environment

+ Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools

+ Experience in automation and manufacturing execution system (MES), process modeling and process improvement

+ Experience in deviation management, troubleshooting and resolving manufacturing anomalies

+ Direct Team Management Experience

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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, Monday - 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”.

The salary range for this role is

$139,600.00 - $219,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Applied Engineering, Applied Engineering, Budget Management, Business, Business Acumen, Calibration Management Software, Calibration of Equipment, Cross-Functional Teamwork, Deviation Investigations, Engineering Principle, Engineering Standards, Estimation and Planning, General Safety, GMP Compliance, Identifying Customer Needs, Leadership, Maintenance Management, Maintenance Planning Software, Maintenance Supervision, Management Process, Managing Engineering Teams, Manufacturing Scale-Up, Preventive Maintenance, Production Improvement, Project Management {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/13/2025

*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:** R349903