Calibration Engineer

Job Description

The Associate 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 FLASH project. 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.
• Participate in 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 instrument 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.
• Support projects with the potential to lead projects for 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:

• High school diploma
• 3 years of experience in field calibration or metrology.
• Project Management experience
• Strong planning, scheduling, and time management skills
• 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

Preferred Education, Experience and Skills:

• Bachelor's Degree or higher in Engineering, Science or related field.
• 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.)

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. MSJR 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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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:05/18/2024

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:R291875