Sr. Spclst, Engineering
Sr. Spclst, Engineering
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Job Description
Job Description
Join our dynamic Engineering Maintenance & Utility Department as a Senior Specialist where you will play a crucial role in enhancing asset reliability and driving manufacturing excellence in a fast-paced environment. Utilize your engineering expertise and leadership skills to empower teams solve complex technical challenges and ensure compliance with industry standards while making a tangible impact on our operational success.
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials intermediates and finished products.
The Sr. Specialist Calibration Engineer is a member of the Engineering Maintenance and Site Services (EMSS) team providing support to the Durham sites. This includes Energy Center Vaccine Bulk and Manufacturing Facilities Quality Labs Material Management Storage Facility (MMSF) and projects when necessary. At times support may extend to the Durham-Teknika site when requested. This position will focus on maintaining the calibration program including implementation of new instruments for calibration investigation into instrument events and continuous improvement by through analysis of instrument performance.
General Profile:
Individual contributor role working with calibration teams across the site with limited oversight to focus instrument performance and minimize downtime.
Initiate and complete SOP revisions.
Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.
Review and approve out of tolerance (OOT) records and ensure quality notifications follow when required.
Facilitate scheduling of calibration activities with the Planning and Scheduling team.
Anticipates and interprets client and/or customer needs to identify solutions.
Works as a liaison between Maintenance Deviation Management Quality and other Site Business Partners.
Initiate Review or Approve changes in the Calibration system (ProCal).
Manage approved vendors for calibrations not performed by site personnel.
Participate in site shutdown meetings ensuring calibration activities are tracked to completion.
Participate in RBAM updates for the whole site.
Establish Metrics to monitor performance of instruments and be able to identify trends.
Work with project personnel to ensure appropriate instrument turnover to site.
Expand knowledge into other systems capable of managing change in the pursuit of continuous improvement.
Lead projects for a facility or the site.
Able to train individuals in the execution of calibration work for the site.
Capable technical writing skills able to document assessments used to justify changes to instrumentation.
The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety compliance automation equipment process and people) in order to best understand and identify root cause.
This position is a 1st 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 teams objectives vision and goals.
Required Education Experience and Skills:
Bachelors Degree or higher in Engineering Science or related field.
6 years of experience in field calibration metrology or equipment reliability.
Project Management experience
Familiarity of regulatory requirements in accordance with GMP manufacturing operations
Good oral and written communication skills
Experience with GMP compliant calibration databases
Experience with formal problem-solving techniques such as root cause analysis (RCA) failure mode effects analysis (FMEA) and/or Lean Six Sigma tools.
Technical writing and deviation investigation experience
Experience in problem solving and troubleshooting.
Preferred Education Experience and Skills:
Project Management experience
Familiarity of World Class maintenance practices is paramount (e.g. PMs RCM PdM etc.)
ProCal or similar digital calibration system experience.
Familiar with data analysis tools to analyze large amounts of data (ex. PowerApps Spotfire)
cGMP experience in a sterile bulk or finished pharmaceutical environment.
Mechanical functionality and reliability knowledge (asset management)
Certified Maintenance Professional (CMRP CRL etc.)
Current Employees apply HERE
Current Contingent Workers apply HERE
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 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 anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
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 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
$114700.00 - $180500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Equipment Qualification Facility Management Good Manufacturing Practices (GMP) Maintenance Supervision Occupational Safety and Health Team Leadership Troubleshooting Vaccine ManufacturingPreferred Skills:
Job Posting End Date:
08/5/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
