Job Description

Job Description

Lead Technician, Calibration and Maintenance (O4)

Lead Maintenance Technician will be a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.

The Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility project/manufacturing support. Develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP PM transactions and calibration activities including creating change control records and non-maintenance notifications. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.

Responsible for supporting:

• Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)

• Support Equipment (e.g. washers, autoclaves, tube welders/sealers)

• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)

• Clean-In-Place (CIP) Systems

• Utility Systems (e.g. Clean-In-Place (CIP), Instrument Air (IA), Clean Dry Air (CDA), tempered glycol, chilled water, utility water)

• Maintenance Equipment (e.g. tools and calibration equipment)

• Support to Digital Platforms (eg. 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

• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

• Decisions are guided by policies, procedures and business plan; receives guidance from manager

• Manage multiple priorities and advance several tasks in parallel

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.

• Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.

• Develops standard operating procedures (SOPs), engineering change request (ECRs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.

• Order and maintain spare parts for assigned process equipment

• Capable of calibration tasks such as temperature, conductivity, pressure, flow, pH, and humidity

• 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 mechanical 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 shift schedule, including holidays and alternating weekends. Required to support an on-call schedule for off-days and weekends.

Required Education, and Experience

• High School Diploma/GED or higher and five years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical.)

• 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

• Installation, 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, DeltaV, and ProCal

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 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 strong leadership skills, and good oral and written communication skills.

• Strong planning, scheduling, and time management skills.

• Available for “On-Call” work rotation (during off-hours) and weekend overtime, as needed.

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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 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

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening, 3rd - Night

Valid Driving License:

No

Hazardous Material(s):

Oils

Job Posting End Date:

12/13/2024

*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.