Job Description

Job Description:

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 thorough 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 team's objectives, vision, and goals.

Required Education, Experience and Skills:

• Bachelor's 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.)

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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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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".

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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

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Requisition ID:R333453