Senior Maintenance Technician/Night Shift

Job Description

The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibilityproject/manufacturingsupport. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities.

Responsible for performing and completing 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.

Responsible for supporting:

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

• Support Equipment (e.g. washers, autoclaves, tubewelders/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

• 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.

• 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 environmentalrequirements/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. Required to support an on-call schedule for off-day and weekends. Successful candidate will be required to work an 8-hour weekday schedule until shift is required.

Position Qualifications:

Education Minimum Requirement:

• High School Diploma/GED or higher

Required Experience and Skills:

• Two years of plant maintenance and/or calibration experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems) or 4 years of military experience in the maintenance and/or calibration career fields

• Required Experience andfamiliarity of regulatory requirements in accordance with GMP manufacturing operations

Preferred Experience and Skills:

• Five years of plant maintenance and/or calibration experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems or 6 years of military experience in the maintenance and/or calibration career fields

• Associate's 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, 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 for extended periods of time

• 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), CMMSCalibration/MaintenanceDatabase 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.

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NOTICEFORINTERNALAPPLICANTS

InaccordancewithManagers'Policy-JobPostingandEmployeePlacement,allemployees subjecttothispolicyarerequiredtohaveaminimumoftwelve(12)monthsofserviceincurrent positionprior toapplyingfor openpositions.

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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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