Senior Calibration Technician

FCX Performance • Milwaukee, WI

6d • Onsite

About The Position

PCI is seeking a Senior Calibration Technician for its Midwest field service team. The role performs and oversees calibration, maintenance, qualification, preventive maintenance, and repair of process, utility, and laboratory instrumentation at client biotechnology facilities in Sheboygan Falls, Wisconsin. Example equipment includes refrigerators, freezers, transmitters, monitors, incubators, centrifuges, autoclaves, pipettes, balances, and pressure and temperature devices. The role is full-time and non-exempt. Travel may reach 75% depending on project and client needs; travel for this specific position is projected to be much lower for now.

The technician ensures work is completed safely and accurately, with timely GxP documentation and in accordance with PCI and client policies and procedures. As a senior technical resource, the role troubleshoots issues, develops effective long-term solutions, provides guidance and training to colleagues, and helps clients evaluate and implement value-added services. The role also supports strategic client relationships and may lead projects or serve as an account manager for select clients.

The position reports directly to a Team Leader, Manager, or Director, depending on the organizational structure. PCI serves pharmaceutical, biotechnology, medical device, and clinical research industries with calibration, commissioning, and consulting services. Its personnel work within quality guidelines enforced by the FDA, EPA, and ISO/IEC 17025:2017.

Requirements

• A four-year degree in life sciences, engineering, electronics, or another related technical field; or equivalent military training and more than four years of applicable metrology, instrumentation, or calibration experience; or an equivalent combination of education and experience.
• Quality system and pharmaceutical experience.
• Expert knowledge and application of instrument, equipment, and loop calibrations across manufacturing, utility, and laboratory environments.
• Exceptional Computerized Maintenance Management System (CMMS) skills.
• Ability to use MAS500 Pivot Table and project KPI module to support management of Labor Utilization Reports and project expenses.
• Ability to interpret government regulations and instrumentation and calibration principles.
• Excellent communication and problem-solving skills with clients and coworkers.
• Thorough knowledge of electrical panels and safety practices.
• Excellent negotiation skills, including developing strategies for complex issues and implementing negotiation processes aligned with PCI objectives.
• Ability to influence and guide others effectively.
• Understanding of business cases and financial issues, including profit-and-loss implications.
• Strong analytical skills and attention to detail while maintaining focus on strategic company goals.
• Strong working knowledge of FDA and GMP and GLP compliance, and NIST traceability.
• Expert knowledge of test equipment and its capabilities, including tolerance requirements and 4:1 test accuracy ratio (TAR).

Nice To Haves

• External certification such as ISA or ASQ.
• Experience with computer-based calibration tracking programs (CMMS) is desired.
• Active involvement in an external professional organization such as ISPE, ASQ, or PDA.

Responsibilities

• Oversee calibrations, qualifications, and preventive maintenance, ensuring accurate and timely GxP documentation, safe work, and compliance with PCI and client policies and procedures.
• Provide technical guidance and effective solutions to clients and PCI technical resources.
• Mentor colleagues and model PCI’s philosophy and values; train associates in proper equipment use and handling.
• Ensure PCI- and client-owned equipment is properly handled and maintained.
• Develop client quotes and proposals.
• Plan projects, including schedules, time codes, test equipment, documentation, resource allocation, and client requirements.
• Manage scheduling, resource allocation, proposals and quotations, Labor Utilization Reports, and fixed-cost and time-and-expense project profitability.
• Identify project scope changes, communicate them to clients, and process scope-change documentation so time coding and billing remain accurate.
• Assess project safety concerns and ensure PCI team members comply with client and PCI site safety requirements.
• Assess client environments, needs, and requirements and develop and implement effective solutions.
• Build client relationships, proactively seek opportunities to expand PCI services, and provide strategic direction.
• Lead projects and serve as account manager for select clients when appropriate.
• Develop and update PCI policies and procedures, interpret government regulations and calibration principles, and assist clients with policy and procedure development or revision.
• Provide onboarding support, on-the-job training, and specialized technical training.
• Participate actively in an external professional organization such as ISPE, ASQ, or PDA.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior