Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
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.
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.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.