United States onlyJob Description
The Mechanical Services Engineer position will ensure the reliable performance of equipment by 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 Mechanical Services Engineer must be able to self-identify opportunities for improvement and execute with minimal supervision.
Responsibilities:
Analyzes maintenance, equipment and calibration performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability.
Identifies 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.
Work 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.
Helps establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities.
Leads deviation investigations for instruments, equipment, and system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments
Lead 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.
Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance.
Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
Support safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective.
Collaborates with the production area maintenance technicians and engineers to maintain all production equipment.
Collaborates with the Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area specific reliability actions.
This position is a 2nd shift position with the potential for infrequent off shift work as needed to support business results. This position is expected to work as an independent member of an integrated team focused on achieving the team’s objectives, vision, and goals. This position could be used to support any of the manufacturing facilities on the Durham site.
Education:
Bachelor of Science in Engineering with two (2) years of production and/or calibration and/or maintenance background
Or
Master of Science in Engineering
Experience and Skills:
Required:
Good planning, scheduling, and time management skills
Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
Good oral and written communication skills
Qualify and Maintain Grade” A” gowning.
Experience with GMP compliant maintenance databases.
Experience including change control and equipment qualification.
Preferred:
cGMP experience in a sterile, bulk or finished pharmaceutical environment.
Experience with Clean Utilities, to include Reverse Osmosis systems, WFI generation and distribution.
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, process modeling and process improvement.
Experience with deviation management, troubleshooting and resolving manufacturing anomalies.
Experience with Lyophilization and/or Filling Manufacturing Processes and equipment
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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 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:
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.
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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, 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
$85,600.00 - $134,800.00This 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
2nd - EveningValid Driving License:
NoHazardous Material(s):
Cleaning suppliesRequired Skills:
Adaptability, Adaptability, Calibration Management Software, Computerized Maintenance Management Systems (CMMS), Critical Thinking, Data Analysis, Driving Continuous Improvement, Electrical Systems, Engineering Design, Equipment Maintenance, General Safety, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Processes, Mechanical Troubleshooting, Process Improvement Management, Process Improvement Projects, Process Improvements, Regulatory Compliance, Reverse Osmosis Plant, Root Cause Analysis (RCA), Safety Management, Safety Procedures, System Maintenance, Teamwork {+ 1 more}Preferred Skills:
Condition-Based Maintenance, Corrective and Preventive Action (CAPA), Lean Six Sigma (LSS), Manufacturing, Planned Maintenance, Predictive Maintenance, Problem Solving, Reliability Centered Maintenance (RCM), Six Sigma, Standard Operating Procedure (SOP), Written CommunicationJob Posting End Date:
06/20/2025*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.
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