Senior Specialist Quality, Maintenance & Reliability Engineering

Job Description
Our company is commissioning and qualifying a new manufacturing facility to significantly expand its production capacity for a medicine used for the treatment of certain forms of bladder cancer. Once this new facility is fully operational, our company will have the capacity to triple the current manufacturing volume of the product, which is expected to support anticipated product demand for the future.
Our Quality Engineering (QE) group, a part of Quality Assurance (QA), is seeking a Senior Specialist that will support the commissioning, qualification, start up, and transition to full commercial manufacturing operations.- The successful candidate will interact directly with Engineering Maintenance Site Services (EMSS), Warehouse operations, and Quality Operations in support of Project Flash's priorities and deliverables.--
This position will be responsible for Quality Assurance (QA) collaboration, review, and approval of EMSS, Warehouse, and QO Lab documentation, protocols, procedures, calibration and maintenance program documentation, and change management (change requests) activities.--- Additionally, this position will support sustainment of all qualified critical utility systems, facility room classification qualification (HVAC), and Environmental Monitoring Performance Qualification (EMPQ) activities.- Position Responsibilities :-
Report to the Quality Assurance (QA) organization, independently manage QA/QE project assignments.- Provide cGMP documentation support (review and approval) of EMSS, Warehouse, and QO lab documentation (e.g., qualification protocols, technical studies, change controls, SOPs, Work Instructions, Job Aids, Preventive Maintenance (PM) and Calibration documentation, Quality Risk Assessments (QRAs), and other cGMP related documentation requiring QA review and approval.- Support EMSS, Warehouse, QO lab compliance activities for Environmental, Health, and Safety (EHS) programs (e.g., GEMBAs, checklists, Lock Out Tag Out (LOTO), Hazardous Energy Control Procedures (HECPs), High Risk Work (HRW), Personnel Protection Equipment (PPE)etc.) and environmental compliance to reinforce and maintain a 'Safety First, Quality Always' culture.- Support Shop Floor Quality Assurance (SFQA) and the Technical Operations Deviation Management groups with event assessments, classifications, investigations, corrective and preventative actions, reviews / approvals through current Quality systems (e.g., CLUE and SAP).- Support Project Flash Business Support scheduling team with EMSS utility, B160 scheduled maintenance & calibration shutdown scheduling, and B160 EM activity scheduling.-- Quality review/analysis of calibration, maintenance, and equipment performance reports / work orders to identify adverse trending issues as part of preventive maintenance and improved reliability.- Support EMSS, Warehouse, and QO Lab pre-approval inspection (PAI) readiness activities.- Support EMSS, Warehouse, and QO Lab metric trending activities and related equipment / process change control activities.- Support compliance to Global policies, standards, and procedures.- Support compliance to Durham Site and Building 160 policies and procedures that promote Permanent Inspection Readiness (PIR).- Perform weekly Site GEMBAs (walk-downs) as part of on-going EHS and Quality compliance.- Escalate and collaborate quality and compliance issues as needed through established Tiers.- Education Minimum Requirement :-
Bachelor's degree (BA/BS) in mechanical engineering, systems engineering, chemical engineering, biochemical engineering or other related engineering or science discipline with five (5) years of experience in the pharmaceutical industry or highly regulated industry. OR Master's degree (MA/MS) in mechanical engineering, systems engineering, chemical engineering, biochemical engineering or other related engineering or science discipline-with three (3) years of experience in the pharmaceutical industry or highly regulated industry. - Required Experience and Skills: -
Strong background in cGMP document review and approval (e.g., SOPs, PMs, Work Orders, HECPs).- Strong knowledge of cGMP compliance standards (GES, QMS, EHS, and Site SOPs)- Strong verbal communication and technical writing skills.- Independent, self-directed strong skill sets in project management, planning/scheduling, and time management.- Experience with facility utility systems (plant and process) Preferred Experience and Skills: -
Calibration and Maintenance Management experience using SAP.- Experience with reading engineering drawings, schematics, and conducting field P&ID walk-downs.- Experience with Quality Risk Management (QRM) and Process Hazard Analysis (PHA) principals and systems.- Experience with Supply Chain / Warehouse operations (receiving, shipping, and inventory) Experience with cGMP compliant calibration and maintenance databases (e.g., ProCal, Fiore).- RCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools.- Capital project management experience.- cGMP document / change control management systems (e.g., KNEAT, Veeva Vault, MEDS, PIMS, ProCore, MIDAS, IPI, CLUE, and Kneat).- Building Automation Systems (BAS) (e.g., DeltaV, Siemens, Johnson Controls).- Experience with project scheduling tools / systems (MS Project, P6, Last Planner, Takt Time, Pull Planning)- Deviation Management (DM) Quality Notification (QN) and associated Corrective Action Preventive Action (CAPA) processes.- Software: Microsoft Excel, Power BI-- 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:
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: R290924