Teknika Maintenance Lead

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 Teknika maintenance team. The selected candidate will manage the engineering, maintenance and calibration 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 Teknika 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. GENERAL PROFILE Provides leadership and direction through individual contributors
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 Teknika 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 Executive 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
Education Minimum Requirement: Bachelor's Degree in Engineering, Science or related technical field
Required Experience and Skills: Minimum 8 years of progressive Maintenance leadership experience in cGMP operations (6 Years with a master's degree or MBA: 3 years with a PhD), or military service (US Navy, US Army, US Marine Corps, US Air Force, US Coast Guard) combined experience in the following functions:
Maintenance Supervisor/Manager
Maintenance Planner and Scheduler
Reliability or Maintenance Engineering
Utilities Maintenance and Operations
Experience in introducing Reliability Engineering for Maintenance (RCM, FMEA, Criticality Analysis, PM optimization, RCA, etc.)
Strong planning, scheduling, and time management skills
Working knowledge regulatory requirements in accordance with cGMP manufacturing operations and demonstrated experience of interacting with site, divisional or regulatory audits/inspections.
Good oral and written communication skills
Project management, including change control and equipment qualification
Preferred Experience and Skills: 15 years of Maintenance and Military experience in a GMP regulated industry in the Maintenance field.
SAP experience related to plant maintenance and spare parts procurement systems
Experience running a Reliability Engineering program.
At least seven years of experience in military service (US Navy, US Army, US Marine Corps, US Air Force, US Coast Guard)
Working Knowledge of cGMP for pharmaceutical, Sterile and/or Biologics manufacturing
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.
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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:
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n/a Requisition ID: R291420