Senior Calibration Technician

About the role

Join the Pharmaceutical Calibrations and Instrumentation (PCI) team as a Senior Calibration Technician performing calibration and maintenance on process and analytical instrumentation onsite at client biotechnology facilities in Sheboygan Falls, WI. This position focuses on maintenance, calibrations, and repairs on a variety of instruments including process/utility/laboratory instruments such as refrigerators, freezers, transmitters, monitors, incubators, centrifuges, autoclaves, pipettes, balances, pressure and temperature devices. Computer based calibration tracking program (CMMS) experience is desired. The Senior Calibration Technician reports directly to the Team Leader, Manager, or Director depending on organizational structure. This is a non-exempt position. Up to 75% travel may be required based on project and client needs, though this specific position is projected to require much less travel initially.

Expectations

• Complete calibrations, qualifications, and PMs with accurate and timely GxP documentation, following PCI and/or client specific policies and procedures.
• Take a proactive role in supporting the Team and providing client support; build a high level of trust with internal and client personnel through consistently upholding PCI Values: Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.
• Identify and execute tasks that enhance PCI's ability to provide an 'added value' service for clients; provide guidance and direction on technical issues.
• Troubleshoot issues and assist in providing innovative, creative, effective, and long-term solutions.
• Build a high level of interaction with the Client, Project, and PCI to provide strategic direction; act as a subject matter expert providing high-level direction, tactical thoroughness, reliability, strategic initiative, and consistent follow-through.
• Work closely with clients to evaluate, demonstrate, and initiate value-added solutions and services.

Responsibilities

• Oversee and supervise calibrations, qualifications, and PMs with accurate and timely GxP documentation, ensuring all Team members follow PCI or client specific policies and procedures, and in a safe manner.
• Provide guidance, direction, and effective solutions to clients and PCI technical resources.
• Uphold, mentor, and serve as a role model to other PCI Associates on the PCI philosophy and values through honesty, integrity, self-motivation, teamwork, pride, and commitment.
• Proactively ensure PCI and client owned equipment is handled and maintained properly; train other Associates on proper use and handling.
• Develop client quotes and proposals.
• Provide oversight and project planning including time codes, schedules, test equipment, documentation, and ensure client requirements are met. Responsible for accurate and timely scheduling, resource allocation, proposal and quotation development, Labor Utilization Reports (LURs), fixed cost and T&E project management for profitability.
• Identify scope changes and communicate to client; process scope change request documentation ensuring time coding and billing are accurate regarding the scope change.
• Proactively assess project safety concerns and ensure PCI Team members comply with any and all client and/or PCI site safety requirements.
• Strategically assess client environments, needs, and requirements to develop and initiate effective solutions; deliver successful execution through established solid relationships with clients.
• Take client relations initiative and proactively seek to expand PCI services.
• May lead projects and serve as "Account Manager" for select clients based on strong client ties and business needs.

Skills Required

• Expert knowledge and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments.
• Exceptional Computer Maintenance Management Systems (CMMS) skills; navigate and utilize MAS500 Pivot Table and project KPI module to support team leaders and project managers effectively manage LUR & project expenses.
• Develop and update PCI Policies and Procedures; understand and interpret Government Regulations and instrumentation/calibration principles; provide training and guidance to Tech I and Tech II resources.
• Assist clients with development and revision of policies and procedures as necessary.
• Excellent communication and problem solving skills with clients and coworkers.
• Thorough electrical panel knowledge and safety practices.
• Excellent negotiation skills with direct identification, development, and implementation of negotiation policies and processes in accordance with PCI objectives; develop negotiation strategy on complex issues.
• Significant ability to effectively influence and guide others.
• Understand the business case and have an appreciation of financial issues and profit and loss implications.
• Excellent analytical skills with attention to detail while keeping strategic company goals in focus.
• PCI Trained Mentor; sought after by technical staff for advice in technical or proposal issues, diplomacy, and ethical practices.
• Active in PCI onboarding process; provide both on the job and specialized technical training.
• Strong applied and working knowledge of FDA; GMP; GLP; compliance and NIST traceability.
• Expert knowledge of test equipment and capabilities such as tolerance requirements and 4:1 TAR.
• Actively involved with an external professional organization (ISPE, ASQ, PDA, etc.).
• External certification preferred (ISA, ASQ, etc.).

Experience & Education Required

• A four-year degree in Life Sciences, Engineering, Electronics, other related technical field OR equivalent military training and four plus years of applicable (Metrology, Instrumentation, Calibration) experience OR the equivalent combination of education and experience.
• Quality System/Pharmaceutical experience is required.

Company Overview

PCI serves pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning, and consulting solutions. Calibrations are performed by highly technical, cGMP/GLP-trained personnel knowledgeable in quality guidelines enforced by the FDA, EPA, and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT), a leading industrial distributor offering more than 6.5 million parts to serve MRO and OEM customers in virtually every industry. Founded in 1923, Applied provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services, storeroom services, and inventory management solutions.