Merck
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Lead Tech, Maintenance
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Merck Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering 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 and drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. Key Duties
Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to Process Equipment (e.g., Filling Machine, Lyophilizer), Support Equipment (washers, autoclaves, incubators), Utility Equipment (clean‑steam generators, water‑for‑injection generation/distribution, reverse osmosis skids, compressed gas systems), Automated Systems (DCS, PLC), Clean‑In‑Place (CIP) Systems, Maintenance Equipment (tools and calibration equipment). Assist with execution of calibration, automation, validation and additional testing, as required. Contribute to the performance and results of the department. Identify and resolve technical and operational problems; collaborate with peers to resolve problems that cross into inter‑related units. Assist in the identification, development, and implementation of new systems that enhance operation and/or engineering processes. Quality & Safety Compliance
Develop and execute engineering change requests (ECRs) as necessary. Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to identify root cause. Provide input to investigate deviations and interface with approvers. Perform maintenance and repair of equipment using hazardous energy control procedures. Wear personal protective equipment (safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.) and wear a clean‑room gown during job duties. Support safety initiatives, including shop‑floor audits, lockout/tagout, and hazardous energy control procedure updates. Communication
Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems. Support daily meetings to facilitate flow of information up/down through the organization. Escalate issues as needed to ensure the right support/awareness is given to issues as they arise. Serve as a subject‑matter expert (SME) during tours to provide area/process overview information to visitors/auditors upon request. Provide necessary training for system maintenance as needed. Financial
Order and maintain spare parts for assigned process equipment. Ensure inventory transactions are complete, timely, and accurate. Recognize and communicate opportunities for cost savings. Education Minimum Requirement
Bachelor’s Degree in Engineering, Science or an associate degree and 2 years experience in a production and/or calibration and/or maintenance background. 6 years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi‑stage refrigeration systems).
Required Experience And Skills
Familiarity with regulatory requirements in accordance with GMP manufacturing operations. Good oral and written communication skills. Physical requirements – must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling, and stooping are required. Proficiency in computer systems and applications including Microsoft Office (Word, Excel, Outlook), PLCs, and CMMS calibration/maintenance database systems. Effective maintenance, troubleshooting, and problem‑solving skills. Routine shift will be day. Available for “On‑Call” work rotation (during off‑hours) and weekend overtime, as needed. Preferred Experience And Skills
SAP experience related to plant maintenance and spare parts procurement systems. cGMP experience in a sterile, bulk or finished pharmaceutical environment. Experience authoring PM/calibration job plans and management of spare parts. Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical manufacturing equipment such as washers, autoclaves, skids, tanks, bioreactors, and filtration skids. Ability to read P&ID's, electrical drawings, blueprints, etc. Ability to manage multiple priorities and advance several tasks in parallel. Knowledge of Allen Bradley PLC’s, Siemens Apogee BAS. Refrigeration license. U.S. Hybrid Work Model
Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work model consisting of three total days on‑site per week (Monday‑Thursday, with Friday designated as a remote‑working day), unless business‑critical tasks require on‑site presence. This hybrid model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions or positions covered by a collective‑bargaining agreement, or any position for which the company determines that remote work cannot be reasonably met. Equal Employment Opportunity
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, EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, 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.
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Lead Tech, Maintenance
role at
Merck Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering 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 and drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. Key Duties
Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to Process Equipment (e.g., Filling Machine, Lyophilizer), Support Equipment (washers, autoclaves, incubators), Utility Equipment (clean‑steam generators, water‑for‑injection generation/distribution, reverse osmosis skids, compressed gas systems), Automated Systems (DCS, PLC), Clean‑In‑Place (CIP) Systems, Maintenance Equipment (tools and calibration equipment). Assist with execution of calibration, automation, validation and additional testing, as required. Contribute to the performance and results of the department. Identify and resolve technical and operational problems; collaborate with peers to resolve problems that cross into inter‑related units. Assist in the identification, development, and implementation of new systems that enhance operation and/or engineering processes. Quality & Safety Compliance
Develop and execute engineering change requests (ECRs) as necessary. Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to identify root cause. Provide input to investigate deviations and interface with approvers. Perform maintenance and repair of equipment using hazardous energy control procedures. Wear personal protective equipment (safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.) and wear a clean‑room gown during job duties. Support safety initiatives, including shop‑floor audits, lockout/tagout, and hazardous energy control procedure updates. Communication
Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems. Support daily meetings to facilitate flow of information up/down through the organization. Escalate issues as needed to ensure the right support/awareness is given to issues as they arise. Serve as a subject‑matter expert (SME) during tours to provide area/process overview information to visitors/auditors upon request. Provide necessary training for system maintenance as needed. Financial
Order and maintain spare parts for assigned process equipment. Ensure inventory transactions are complete, timely, and accurate. Recognize and communicate opportunities for cost savings. Education Minimum Requirement
Bachelor’s Degree in Engineering, Science or an associate degree and 2 years experience in a production and/or calibration and/or maintenance background. 6 years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi‑stage refrigeration systems).
Required Experience And Skills
Familiarity with regulatory requirements in accordance with GMP manufacturing operations. Good oral and written communication skills. Physical requirements – must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling, and stooping are required. Proficiency in computer systems and applications including Microsoft Office (Word, Excel, Outlook), PLCs, and CMMS calibration/maintenance database systems. Effective maintenance, troubleshooting, and problem‑solving skills. Routine shift will be day. Available for “On‑Call” work rotation (during off‑hours) and weekend overtime, as needed. Preferred Experience And Skills
SAP experience related to plant maintenance and spare parts procurement systems. cGMP experience in a sterile, bulk or finished pharmaceutical environment. Experience authoring PM/calibration job plans and management of spare parts. Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical manufacturing equipment such as washers, autoclaves, skids, tanks, bioreactors, and filtration skids. Ability to read P&ID's, electrical drawings, blueprints, etc. Ability to manage multiple priorities and advance several tasks in parallel. Knowledge of Allen Bradley PLC’s, Siemens Apogee BAS. Refrigeration license. U.S. Hybrid Work Model
Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work model consisting of three total days on‑site per week (Monday‑Thursday, with Friday designated as a remote‑working day), unless business‑critical tasks require on‑site presence. This hybrid model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions or positions covered by a collective‑bargaining agreement, or any position for which the company determines that remote work cannot be reasonably met. Equal Employment Opportunity
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, EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, 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.
#J-18808-Ljbffr