Instrumentation Specialist

9290 FCX Performance, Inc.•Raleigh, NC

4d•Onsite

About The Position

Join the Pharmaceutical Calibrations and Instrumentation (PCI) team! We are seeking a full time Instrumentation Specialist to perform repairs and maintenance on laboratory equipment at our client's pharmaceutical facilities. Please review the job description below and apply if you would like to be considered. If you prefer working on the go instead of at a desk, have a passion for performing quality work, and have a strong laboratory instrumentation background, this position may be just for you! The Instrumentation Specialist reports directly to the Team Lead, Team Manager or Director. These positions are non-exempt. Up to fifty percent travel may be required but is not currently anticipated. Expectations: The Instrumentation Specialist provides high-level instrumentation field services for clients including calibration services, maintenance services, project services, and some consulting support. The Instrumentation Specialists may also support the development of or develop/provide internal and/or external technical training. The Instrumentation Specialist is expected to provide onsite process and/or analytical services as it relates to startup projects, installations, fixed-duration, and long term contracts for existing facilities. They consistently uphold PCI Values and demonstrate Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment. This position is eligible for company vehicle, annual bonus and sign on bonus.

Requirements

Expert in-depth knowledge and application of a wide variety and type of instrumentation, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments.
Exceptional Computer Maintenance Management Systems (CMMS) skills.
High attention to detail.
Strong written skills, with the ability to develop and create quotes or proposals.
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. Develops negotiation strategy on complex issues. Significant ability to effectively influence and guide others.
Understands the business case and has an appreciation of financial issues and profit and loss implications. Excellent analytical skills with attention to detail while keeping strategic company goals in focus.
Sought after by technical industry for advice on technical issues. Provides 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.
Involved with an external professional organization (ISPE, ASQ, PDA, etc.).
Ability to interpret proposals and coordinate activities to accomplish the approved scope.
Extensive instrumentation and controls troubleshooting skills.
Extensive experience with Microsoft Office Suite.
Understanding of Validation principles and how it relates to calibrations.
Thorough understanding and troubleshooting capability with incubators, centrifuges, balances, refrigerators and freezers, stability chambers, chromatography (HPLC or GC), spectrophotometers, other general laboratory equipment as needed per clients.
Dependent upon client needs, may require thorough understanding and working capability with RT-PCR, bio analyzers, gel imagers, scintillation counters, and cytometers; Histology Equipment, such as microtomes, slide strainers, tissue processors, harvesters, homogenizers, and microscopes; and/or Liquid Automation / Robotics / HTS, such as liquid handlers, plate stackers, plate readers, and plate washers.
A two-year or four-year degree in Engineering, Management, Life Sciences, or other related technical field (or equivalent military training) and four or more years of intense instrumentation experience in the Pharmaceutical/Quality industry or the equivalent combination of applicable education and experience.

Responsibilities

Conducts high level and technically complex repairs, calibrations, qualifications, and PM’s with accurate and timely GxP documentation, following PCI or client specific policies and procedures, and in a safe manner.
Provides guidance, direction and effective solutions to clients and PCI technical resources.
Proactively takes steps to ensure PCI and client owned equipment is handled and maintained properly, as well as trains other associates on proper use and handling.
Development of client quotes and proposals.
Identifies and initiates scope changes and communicates to client, as well as, processes the scope change request and uses proper documentation ensuring that time coding and billing are accurate with regard to the scope change.
Proactively assesses project safety concerns and ensures PCI team members are in compliance with any and all client and/or PCI site safety requirements.
Strategically assesses client environments, needs, and requirements to develop and initiate effective solutions and through established solid relationships with clients, delivers successful execution.
May lead projects and serve as “Account Manager” for select clients based on strong client ties and business needs.
Understands and executes GMP and compliance practices as it relates to PCI clients and their instrumentation needs.
Resource scheduling, account management and maintaining PCI client/project files in accordance with company procedures.
Develops functional instrument requirements and procures instruments for clients.
Performs and oversees equipment services and instrument procurement, partnering with and assisting third party technical services.