Instrumentation/Calibration Technician II

Minaris Regenerative Medicine Co., Ltd.; Allendale (NJ); On-site; USD 70,000 - 95,000; Full time

Job summary

Minaris Regenerative Medicine Co., Ltd. in Allendale, NJ is seeking an Instrumentation and Calibration Technician to provide calibration and instrumentation services at the Allendale site.

The role supports Operations, R&D, QC, QA and other departments, ensuring equipment meets regulatory and quality standards in GMP and non-GMP areas. You will calibrate, verify, install, repair and maintain instrumentation, log data in CMMS, review contractor reports, manage spare parts, and uphold GDP and FDA

Qualifications

• Bachelor’s degree and 3–5 years calibration experience or equivalent work background.
• Experience calibrating instruments such as controllers, transmitters, loggers and sensors.
• Pharma/Life Sciences/medical device background preferred.
• Proficient with basic computer tools and GDP/FDA quality practices.

Responsibilities

• Calibrate measurement and control instrumentation (temperature, pressure, pH, etc.).
• Complete calibration data sheets in CMMS.
• Assist in managing contractors and review service reports.
• Identify critical spare parts for repairs and maintenance.
• Ensure compliance with cGMP, GDP and SOPs.

Skills

Diagnostic skills

Problem-solving

Communication skills

Self-motivated

Education

Bachelor's degree in a related field

Tools

CMMS

Job description

Position Summary:

The Instrumentation and Calibration Technician is based at our Allendale site and is responsible for providing instrumentation/calibration services, which includes but not limited to; Calibrations, verifications, installations, repairs, troubleshooting, inspections, maintaining measurement and test equipment, controlling devices, data logging, communication and telemetry systems, and performs related work as required. The position will support Operations, R&D, Supply Chain, QC, QA and other departments as assigned, ensuring the best operation practices for overall facilities’ needs in GMP and non GMP areas.

Essential Functions and Responsibilities:

• Calibrate a variety of measurement and/or control instrumentation, including but not limited to controllers, indicators, transmitters, and loggers. Measurement parameters including but not limited to temperature, pressure, speed, mass, time, pH, CO2 content and humidity.
• Complete calibration data sheets in CMMS (Computerized Maintenance Management system) as required
• Assist in managing contractors and reviewing their service reports to ensure compliance.
• Assist in identifying critical spare parts for potential repairs and/or maintenance.
• Complete walk-through inspections of devices and respective labeling.
• Perform Preventative Maintenance on various instrumentation, such as incubators, centrifuges, refrigerators, and freezers
• Maintain records of Measurement and Test Equipment ensuring compliant Test Accuracy Ratios
• Maintain proper stock, parts, tools, and safety equipment.
• Review contractors physical work and paperwork for technical accuracy and comply with cGMP, GDP, and Company SOP’s.

Competencies:

• Commitment to Excellence-demonstrates a commitment to competently perform his/her job duties and responsibilities within established time frames.
• Continuously strives to improve work performance.
• Accepts responsibility for his/her commitments to the company.
• Willing to accept new projects and/or commitments.
• Arrives to work on time prepared and ready to contribute.
• Candidate must be self-motivated and be able to quickly ramp-up on the understanding of existing plant processes.
• Strong interpersonal and communication skills including demonstrated writing skills

Desire to learn and develop career within organization Supervisory Responsibility

• The position may be required to supervise contractors performing work onsite.

Qualifications:

• Ability to manage multiple responsibilities with a degree of self-motivation.
• Bachelor’s degree and 3-5 years general calibration experience, or equivalent work experience.
• Previous experience in pharmaceutical/Life Sciences/medical device preferred.
• Demonstrated diagnostic and problem-solving skills in a team environment • Must have general computer competency using email, Microsoft Word, and Excel.
• Preferred experience working with CMMS software. Quality Requirements
• Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Attend all required Quality & Compliance training at the specified interval. Minimum Required Training
• Must understand and adhere to Good Documentation Practices (GDP)
• Must train and become gown qualified to enter and work in classified manufacturing areas.
• Maintain 100% training records for all required training.
• Valid driver’s license and clean driving record Working Environment
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• Must have the ability to work in the cleanroom environment for an extended period
• Must have the ability to work with specialized equipment, such as CO2 measurement probes
• Must be able to work during the weekend, holidays and as required by the company
• Must have the ability to work in a team-oriented environment and with clients
• Must be able to handle the standard/moderate noise of the manufacturing facility
• This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space.

Physical Requirements:

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

• Lift up to 50 pounds; can push, pull, carry, or maneuver heavier items (with additional manpower or appropriate devices
• The employee is frequently required to lift, move, or carry up to 30 pounds
• Must be capable of moving, sitting, stretching, stooping, kneeling, crouching, and reaching, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.
• Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
• Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone
• Ability to climb stairs and a ladder and maintain balance Other Duties
• Provide 24-hour emergency response as required and be available to work nights or weekends to service company needs.

Disclaimer:

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice