Mechanical Services Engineer

Job DescriptionThe Mechanical Services Engineer is a member of the Engineering and Maintenance team providing technical support within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.The Mechanical Services Engineer position will ensure the reliable performance of equipment during by provide 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 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. This position could be used to support any of the manufacturing facilities on the Durham site.Education:

Associates Degree with two (2) years of production and/or calibration and/or maintenance background

Or

Bachelor of Science in Engineering

Required Experience and Skills:

Strong planning, scheduling, and time management skills

Working knowledge of regulatory requirements in accordance with GMP manufacturing operations

Good oral and written communication skills

Experience with GMP compliant maintenance databases

Project management experience including change control and equipment qualification

Experience with plant utility systems

SAP Knowledge, experience

Preferred Experience and Skills:

cGMP experience in a sterile, bulk or finished pharmaceutical environment

Experience with automated drug product filling, lyophilization, and inspection equipment.

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 and manufacturing execution system (MES), process modeling and process improvement

Experience in deviation management, troubleshooting and resolving manufacturing anomalies

NOTICE FOR INTERNAL APPLICANTSIn 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.VETJOBSEmployees 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.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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”.Search Firm Representatives Please Read CarefullyMerck & 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/AJob Posting End Date:08/6/2024A 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: 08/06/2024A 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: R303858