FCX Performance
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Instrumentation Specialist
role at
FCX Performance .
The Pharmaceutical Calibrations and Instrumentation (PCI) team is seeking a full‑time Instrumentation Specialist to perform repairs and maintenance on laboratory equipment at our client's pharmaceutical facilities. If you enjoy field work, are passionate about quality, and have a strong laboratory instrumentation background, this role may be for you.
The Instrumentation Specialist reports directly to the Team Lead, Team Manager or Director. This position is 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 Specialist may also support the development of, or develop/provide internal and/or external technical training. The 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: Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.
This position is eligible for a company vehicle, annual bonus, and a sign‑on bonus.
Responsibilities
Conducts high level and technically complex repairs, calibrations, qualifications, and PMs with accurate and timely GxP documentation, following PCI or client policies and procedures, and in a safe manner.
Provides guidance, direction and effective solutions to clients and PCI technical resources.
Proactively ensures PCI and client‑owned equipment is handled and maintained properly, and trains other associates on proper use and handling.
Development of client quotes and proposals.
Identifies and initiates scope changes and communicates to the client, and processes the scope change request with proper documentation ensuring accurate time coding and billing.
Proactively assesses project safety concerns and ensures PCI team members comply with client and PCI site safety requirements.
Assesses client environments, needs and requirements to develop effective solutions and, through solid client relationships, 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 they relate 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.
Skills Required
Expert knowledge and application of instrumentation, equipment, and loop calibrations across manufacturing, utilities, and laboratory environments.
Exceptional CMMS skills.
High attention to detail.
Strong written skills for quotes or proposals.
Thorough electrical panel knowledge and safety practices.
Excellent negotiation skills with the ability to develop and implement negotiation policies and processes in line with PCI objectives. Ability to influence and guide others.
Understanding of business case, financial issues, and profit and loss implications. Strong analytical skills.
Ability to train others and provide technical guidance. Knowledge of FDA, GMP, GLP compliance and NIST traceability. Knowledge of test equipment and tolerance requirements (4:1 TAR).
Active involvement with external professional organizations (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 their relation to calibrations.
Proficient with incubators, centrifuges, balances, refrigerators and freezers, stability chambers, chromatography (HPLC or GC), spectrophotometers and other general laboratory equipment as required by clients.
Depending on client needs, may require knowledge of RT‑PCR, bio analyzers, gel imagers, scintillation counters, cytometers, histology equipment (microtomes, slide strainers, tissue processors, harvesters, homogenizers, microscopes) and/or liquid handling/automation (HTS) equipment.
Experience & Education A two‑year or four‑year degree in Engineering, Life Sciences or related technical field (or equivalent military training) and four or more years of instrumentation experience in the Pharmaceutical/Quality industry, or the equivalent combination of education and experience.
PCI is a FCX Performance Company and a subsidiary of Applied Industrial Technologies. PCI serves pharmaceutical, biotechnology, medical device, and clinical research industries nationwide with calibration, commissioning and consulting solutions. Calibrations are performed by cGMP/GLP‑trained personnel knowledgeable in FDA, EPA and ISO/IEC 17025:2017 guidelines.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, gender identity, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.
Job details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industries: Industrial Machinery Manufacturing
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Instrumentation Specialist
role at
FCX Performance .
The Pharmaceutical Calibrations and Instrumentation (PCI) team is seeking a full‑time Instrumentation Specialist to perform repairs and maintenance on laboratory equipment at our client's pharmaceutical facilities. If you enjoy field work, are passionate about quality, and have a strong laboratory instrumentation background, this role may be for you.
The Instrumentation Specialist reports directly to the Team Lead, Team Manager or Director. This position is 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 Specialist may also support the development of, or develop/provide internal and/or external technical training. The 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: Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.
This position is eligible for a company vehicle, annual bonus, and a sign‑on bonus.
Responsibilities
Conducts high level and technically complex repairs, calibrations, qualifications, and PMs with accurate and timely GxP documentation, following PCI or client policies and procedures, and in a safe manner.
Provides guidance, direction and effective solutions to clients and PCI technical resources.
Proactively ensures PCI and client‑owned equipment is handled and maintained properly, and trains other associates on proper use and handling.
Development of client quotes and proposals.
Identifies and initiates scope changes and communicates to the client, and processes the scope change request with proper documentation ensuring accurate time coding and billing.
Proactively assesses project safety concerns and ensures PCI team members comply with client and PCI site safety requirements.
Assesses client environments, needs and requirements to develop effective solutions and, through solid client relationships, 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 they relate 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.
Skills Required
Expert knowledge and application of instrumentation, equipment, and loop calibrations across manufacturing, utilities, and laboratory environments.
Exceptional CMMS skills.
High attention to detail.
Strong written skills for quotes or proposals.
Thorough electrical panel knowledge and safety practices.
Excellent negotiation skills with the ability to develop and implement negotiation policies and processes in line with PCI objectives. Ability to influence and guide others.
Understanding of business case, financial issues, and profit and loss implications. Strong analytical skills.
Ability to train others and provide technical guidance. Knowledge of FDA, GMP, GLP compliance and NIST traceability. Knowledge of test equipment and tolerance requirements (4:1 TAR).
Active involvement with external professional organizations (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 their relation to calibrations.
Proficient with incubators, centrifuges, balances, refrigerators and freezers, stability chambers, chromatography (HPLC or GC), spectrophotometers and other general laboratory equipment as required by clients.
Depending on client needs, may require knowledge of RT‑PCR, bio analyzers, gel imagers, scintillation counters, cytometers, histology equipment (microtomes, slide strainers, tissue processors, harvesters, homogenizers, microscopes) and/or liquid handling/automation (HTS) equipment.
Experience & Education A two‑year or four‑year degree in Engineering, Life Sciences or related technical field (or equivalent military training) and four or more years of instrumentation experience in the Pharmaceutical/Quality industry, or the equivalent combination of education and experience.
PCI is a FCX Performance Company and a subsidiary of Applied Industrial Technologies. PCI serves pharmaceutical, biotechnology, medical device, and clinical research industries nationwide with calibration, commissioning and consulting solutions. Calibrations are performed by cGMP/GLP‑trained personnel knowledgeable in FDA, EPA and ISO/IEC 17025:2017 guidelines.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, gender identity, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.
Job details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industries: Industrial Machinery Manufacturing
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