Instrumentation Specialist

9290 FCX Performance, Inc.•Raleigh, NC

88d•Onsite

About The Position

The Instrumentation Specialist performs repairs and maintenance on laboratory equipment at client pharmaceutical facilities and provides high-level instrumentation field services, including calibration, maintenance, project services, and some consulting support. The role may also involve developing or delivering technical training and providing onsite process and/or analytical services for startup projects, installations, fixed-duration engagements, and long-term contracts at existing facilities. The position reports directly to a Team Lead, Team Manager, or Director and is non-exempt. Up to 50% travel may be required, although travel is not currently anticipated. The position is eligible for a company vehicle, annual bonus, and sign-on bonus. The Instrumentation Specialist handles technically complex repairs, calibrations, qualifications, and preventive maintenance while completing accurate, timely GxP documentation and following applicable safety and procedural requirements. The specialist advises clients and PCI technical resources, supports client relationships and account management, and may lead projects for select clients. Work also includes developing quotes and proposals, managing scope changes, scheduling resources, maintaining project files, procuring instruments, and coordinating third-party technical services. The role requires knowledge of GMP and compliance practices relevant to PCI clients and their instrumentation needs. PCI serves pharmaceutical, biotechnology, medical device, and clinical research industries nationwide with calibration, commissioning, and consulting solutions. Its personnel are trained in cGMP/GLP and work with 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. Applied describes its philosophy as putting people first and states its commitment to fair treatment and growth opportunities for all employees.

Requirements

Two-year or four-year degree in Engineering, Management, Life Sciences, or another related technical field, or equivalent military training, combined with four or more years of intensive instrumentation experience in the pharmaceutical/quality industry; an equivalent combination of applicable education and experience is acceptable.
Expert, in-depth knowledge and application of a wide variety of instrumentation, equipment, and loop calibrations across manufacturing, utilities, and laboratory environments.
Exceptional Computerized Maintenance Management Systems (CMMS) skills.
High attention to detail and strong written skills, including the ability to develop quotes and proposals.
Thorough electrical panel knowledge and safety practices.
Excellent negotiation skills, including the ability to identify, develop, and implement negotiation policies and processes aligned with PCI objectives; develop strategies for complex issues; and influence and guide others.
Understanding of business cases, financial issues, and profit-and-loss implications; strong analytical skills that balance detail with strategic company goals.
Strong technical expertise sufficient to advise others and provide on-the-job and specialized technical training.
Applied working knowledge of FDA, GMP, and GLP compliance and NIST traceability.
Expert knowledge of test equipment and capabilities, including tolerance requirements and 4:1 test accuracy ratio (TAR).
Ability to interpret proposals and coordinate activities to deliver the approved scope.
Extensive instrumentation and controls troubleshooting skills.
Extensive experience with Microsoft Office Suite.
Understanding of validation principles and their relationship to calibrations.
Thorough understanding and troubleshooting capability with incubators, centrifuges, balances, refrigerators and freezers, stability chambers, HPLC or GC chromatography, spectrophotometers, and other general laboratory equipment as required by clients.

Nice To Haves

Involvement with an external professional organization such as ISPE, ASQ, or PDA.
Depending on client needs, thorough understanding and working capability with RT-PCR, bio analyzers, gel imagers, scintillation counters, cytometers, histology equipment, or liquid automation, robotics, and high-throughput screening equipment.

Responsibilities

Conduct technically complex repairs, calibrations, qualifications, and preventive maintenance, completing accurate and timely GxP documentation in accordance with PCI or client procedures and safety requirements.
Provide guidance, direction, and effective solutions to clients and PCI technical resources.
Ensure PCI- and client-owned equipment is handled and maintained properly, and train associates in proper use and handling.
Develop client quotes and proposals.
Identify and initiate scope changes, communicate them to clients, process scope-change requests, and ensure proper documentation, time coding, and billing.
Assess project safety concerns and ensure PCI team members comply with applicable client and PCI site safety requirements.
Assess client environments, needs, and requirements; develop and initiate solutions; and execute work through established client relationships.
Lead projects and serve as an account manager for select clients when client relationships and business needs warrant it.
Understand and execute GMP and compliance practices relevant to PCI clients and their instrumentation needs.
Schedule resources, manage accounts, and maintain PCI client and project files in accordance with company procedures.
Develop functional instrument requirements and procure instruments for clients.
Perform and oversee equipment services and instrument procurement, partnering with and assisting third-party technical services.
Provide or support development of internal and external technical training.