Senior Specialist, Engineering Maintenance - Durham, United States - Merck

Description

Job Description

Our Engineers support internal and external manufacturing operations remain operational, 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.

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 HPV 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.

The Senior Engineering Specialist will troubleshoot and maintain process and process support equipment utilized in a new HPV vaccine drug substance manufacturing operation. Develops Standard Operating Procedures (SOP's) and Preventative Maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.

Responsible for supporting:

• Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)
• Support Equipment (e.g. washers, autoclaves, tube welders/sealers)
• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
• Process Utility Systems (e.g. Clean-In-Place (CIP) Systems, Water for Injection (WFI), and Clean Steam (CS))
• Maintenance Equipment (e.g. tools and calibration equipment)
• Must be flexible to perform all the following functions and other tasks, as needed:
• Authors SOPs, PM job plans, and change control requests related to equipment modifications.
• Manages small projects for equipment/maintenance related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts.
• Interact with vendors and support project coordination activities like FAT, SAT, Design Reviews, and Engineering assessments.
• Interfaces with vendors as required for equipment testing, parts, and troubleshooting.
• Ensures appropriate spare part inventories are established and maintained.
• Actively supports safety initiatives, including shop floor audits, HAZOp reviews, Lock-out.
• Tag-out (LOTO) and Hazardous Energy Control Procedure (HECP) updates.
• Performs in-depth troubleshooting and maintenance of equipment in support of the production schedule.
• Provides training to others, as required.
• Completes written documentation of work performed.
• Executes SAP transactions including spare parts management and PM change control.
• Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders with an emphasis on reducing reactive work and increasing reliability.
• Collaborates with reliability engineers to conduct periodic RBAM assessments and own area specific reliability actions.
• Supports equipment and instrumentation related atypical investigations, as required.
• Ability to lift/move materials/equipment weighing up to 100 pounds.
• Effective communication
• Responsible for working as part of an inclusive team to achieve site mission, vision and goals through:
• Efficient and safe operation of equipment
• Compliance with current good manufacturing processes (cGMP)

Education Minimum Requirement:

• Bachelor's Degree required: prefer Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field.

Required Experience and Skills:

• Five (5) years of relevant experience; a Master of Science Degree with a minimum of three (3) years of relevant experience; or a Ph.D. with relevant academic experience.
• Experience in a manufacturing environment with responsibility for mechanical troubleshooting and repair of automated equipment.
• SAP experience related to plant maintenance and spare parts procurement systems.
• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
• Ability to work in a highly effective team environment.
• Strong communication (written/verbal) skills.
• Ability to manage multiple priorities; strong planning, scheduling, and time management skills.
• Ability to work with and troubleshoot computer control equipment including Programmable Logic Controllers (PLC) and/or Distributed Control Systems (DCS)
• Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel, Outlook and PowerPoint), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.

Preferred Experience and Skills:

• Plant maintenance/calibration, project engineering and/or operations experience.
• Experience authoring PM/calibration job plans and management of spare parts - SAP or similar.
• Project management experience including change control and equipment qualification.
• Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical manufacturing equipment such as washers, autoclaves, CIP skids, tanks, bioreactors, and filtration skids.
• Six Sigma green and/or black belt certification

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. VETJOBS #EBRG

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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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".

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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:05/25/2024

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:R293153