Sr. Tech, Operations

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 Senior Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. 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 and/or Lead 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 Departments to help the company and all of its personnel to reach their goals in providing a safe clean and efficient environment.

Shift: 12-hour 2-2-3 Day Shift

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

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

• Knowledge of instrumentation PLCs and electronic and pneumatic loop control systems

• Perform routine calibrations of instrumentation.

• Perform maintenance troubleshooting repair design installation and configuration of equipment instrumentation and control systems

• Perform out of tolerance reports

• Maintains calibration standards

• 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.

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 to preventative maintenance (PM) plans/calibration procedures task lists etc. as required.

• Assists with execution of automation validation and additional testing as required

• Responsible for written documentation of activities

• Completes preventative maintenance and calibration work orders

• 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&IDs electrical drawings blueprints etc.

• Routine shift will be a 12-hour 2-2-3 Day Shift schedule including holidays and alternating weekends. Required to support an on-call schedule for off-day and weekends.

• 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.

• Experience in calibration and process control experience involving but not limited to Conductivity Flow Level pH Pressure Temperature Speed and Weight RH Gas Concentrations Electrical etc.

Required Education and Experience

• High School Diploma/GED or higher and four (4) years of plant maintenance experience with knowledge of technical craft skills (instrumentation electrical and 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

• 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.

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

#MSJR

Required Skills:

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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 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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