Calibration Technician II

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

Performs calibration testing on laboratory and plant equipment to assure they are calibrated correctly and are providing accurate measurements.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Ability to read and interpret procedures in order to perform routine calibration of various devices such as temperature, pressure, flow, and humidity instrumentation as assigned.

• Willingness to be "hands on" and understand new technology required.

• Produce and maintain the proper paperwork (data sheets, certificates, stickers, etc.) in an organized and controlled manner in compliance with Good Manufacturing Practices and Good Documentation Practices.

• Review certificates for correctness.

• Document the performance of calibration activities according to priorities and policy.

• Manage workload to achieve production schedules and ensure completion within timeframe.

• Assist with customer and regulatory audits as needed.

• Reporting OOS results when results fall out-with the expected ranges and performing instruments adjustments where applicable.

• Ability to coordinate with external calibration vendors to service instruments and equipment.

• Ensure that assets and supplies are maintained and stored properly.

• Advanced troubleshooting, analytical and problem solving skills.

• Ability to communicate effectively with vendors, clients and all levels of staff.

• Responsible for the inspection, maintenance, and repair of instruments and equipment to ensure they are calibrated correctly and provide accurate measurements.

• Maintains and communicates calibration schedule.

• Supports on-boarding of new equipment and instruments.

• Supports deviation and investigation documentation related to calibration issues.

• Experienced in utilizing and calibrating tools and test equipment.

• Identifies, escorts and manages calibration service contractors for calibrations and instrumentation / system repairs.

• Keep an inventory of the calibration laboratory's fixed assets and consumable supplies that can affect the quality of calibration results.

• Schedule and document the performance of calibration activities according to priorities and policy.

• Data entry and advanced database use in accordance with internal SOPs and external regulatory requirement.

• Identifies, escorts and manages calibration service contractors for calibrations and instrumentation / system repairs.

• Manage calibration and repair of Calibration Standards equipment.

• Working knowledge and understanding of laboratory and production instrumentation and equipment.

• Ability to learn new technical disciplines and apply previous experiences to new task.

• Perform periodic reviews and updates of calibration SOPs and department records.

• Be self-motivated and able to complete assigned tasks unsupervised.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Performs other duties as assigned by Manager/Supervisor.

• Attendance to work is an essential function of this position.

• This position may require overtime and/or weekend work.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Required:

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.

• College Level Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and knows various computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred

• Ability to follow instructions and respond to management direction.

• Ability to identify and resolve problems promptly.

• Ability to display excellent time management skills.

• Ability to demonstrate attention to detail.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.