**Job Description** Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Maintenance and Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates, and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. Under the supervision of the Maintenance Manager, the selected candidate will utilize strong knowledge of precision measurement science (Metrology), mathematics, physics, and electronics to test, calibrate, troubleshoot, maintain and repair instrumentation/controls. All duties must be performed in compliance with established company, department, and safety policies and procedures within GXP-regulated and non-GXP facilities. The incumbent will execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls. The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests. This position will work in conjunction with _Facilities, Engineering, Validation, Manufacturing, and Quality Control Departments_ to help the company and all of its personnel to reach their goals in providing a safe, clean, and efficient environment. **Responsible for supporting:** + Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns) + Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation) + Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS)) + Clean-In-Place (CIP) Systems + Maintenance Equipment (e.g. tools and calibration equipment) + Support to Digital Platforms (e.g. SAP, ProCal, Brady) + Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems + Contributes to the performance and results of the department + Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units + Assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes + Decisions are guided by policies, procedures, and business plan; receives guidance from manager + Strong knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems within the following disciplines: Conductivity, Low Frequency Electromagnetic Flow, Level, Mechanical, Optical, pH, Pressure, Temperature, Time, Speed and Weight. + Perform routine calibrations of instrumentation. Perform maintenance, troubleshooting, repair, design, installation, and configuration of equipment, instrumentation and control systems. + Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and calibration/maintenance procedures. + Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment. + Perform out of tolerance reports, which may include doing reverse traceability. Calibration Drift analysis and executing changes to improve calibration program. + Propose calibration equipment upgrade requirement when needed in order to be in compliance and up to date with calibration orders. + Review’s vendor calibration certificates. + Maintains calibration standards + Redline drawings, engineering documentation and other technical specifications + Identify “Out of Tolerance” conditions and perform corrective actions to return the device to within specification. Participate with investigating and documenting the potential impact that the “Out of Tolerance” condition may have had on the instrumentation and process. + Develop and/or revise calibration procedures and job plans while looking for ways to improve how calibrations and troubleshooting is performed in an attempt to make those practices more efficient. + Provide support and training to peers to improve their abilities and increase their technical knowledge + Assists supervision with the assigning, scheduling and prioritization of work order requests using maintenance management systems. **Must be flexible to perform all the following functions and other tasks, as needed:** + Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves, and CIP skids. + Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment. + Support updates of standard operating procedures (SOPs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required. + Identify spare parts for preventive maintenance plans. + Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems + Assists with execution of automation, validation, and additional testing, as required + Responsible for written documentation of activities + Completes preventative maintenance and calibration work orders, resolves deviations, and evaluates equipment performance for efficient operation. + Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures + Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines + Effective maintenance, troubleshooting, and problem-solving skills required + Ability to manage multiple priorities and advance several tasks in parallel + Demonstrated instrumentation aptitude + Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation. + Ability to read P&ID's, electrical drawings, blueprints, etc. + Routine shift will be 2-2-3, 12-hour day shift schedule, including holidays and alternating weekends. Successful candidate will be required to work an 8-hour weekday schedule until shift is required. + Must possess good organizational, communication and time management skills, with a strong attention to detail, be able to follow Standard Operating Procedures, Calibration Procedures, and work instructions. + Must be self-motivated, able to work both independently and as part of a team with strict adherence to all environmental, health and safety policies and procedures. + Candidates must have good comprehension and work experience using calibration principals, along with basic computer skills. + Broad spectrum of calibration and process control experience involving but not limited to Conductivity, Flow, Level, pH, Pressure, Temperature, Speed and Weight, RH, Gas Concentrations, Electrical, etc. + "Self-starter" attitude and ability to learn and understand new equipment or instrumentation. **Required Education, and Experience** + High School Diploma/GED or higher and **six (6) years** of plant maintenance or equivalent Military experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems) + Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations **Preferred Experience and Skills:** + Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation + Experience working in a clean room or GMP/regulated manufacturing environment + Operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field + Experience with GMP compliant calibration and/or maintenance database systems. + Knowledge of SAP and DeltaV and Procal + Extensive calibration/instrumentation experience + ASQ CCT Certification and or ISA CCST Certification (Any Level) **Physical Requirements** + Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level. + Walking, bending, crawling and stooping are required. . + Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc. + Position requires clean room gowning during performance of job duties **Skills:** + Effective communication both written and oral + Effective Calibration/Instrumentation Skills + Effective maintenance, troubleshooting, and problem-solving skills + Working knowledge of regulatory requirements in accordance with GMP manufacturing operations. + Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems. + Must demonstrate adept leadership skills. + Strong planning, scheduling, and time management skills. + Available for “On-Call” work rotation (during off-hours) and weekend overtime, as needed. \#MSJR **VETJOBS** 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. 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: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ 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. 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 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:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Not Applicable **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Required Skills:** Building Automation Systems, Calibration Management Software, Calibration Procedures, Equipment Maintenance, GMP Compliance, Instrument Calibrations, Lockout Tagout, Mechanical Troubleshooting, Metrology, Programmable Logic Controller (PLC) **Preferred Skills:** **Job Posting End Date:** 08/22/2025 ***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.** **Requisition ID:** R360967