Chromatography Instrument Specialist

The CREW Corporation; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Job summary

The CREW Corporation is seeking a hands-on Maintenance Technician to support a local pharmaceutical company in downtown Indianapolis. You will maintain and repair QC Chemistry and Microbiology equipment across five labs in a regulated GMP environment, performing preventive maintenance and repairs.

You will collaborate with vendors and lab customers to ensure quality, efficiency, and compliance, assist with system and process migrations, and help mentor colleagues while managing multiple tasks in

Qualifications

• Maintenance, repair, complex instrumentation, and troubleshooting experience.
• Regulated GMP environment experience preferred in pharmaceutical or medical settings.
• Scientific/technical documentation and data integrity knowledge.
• Strong teamwork, interpersonal, written, and verbal communication skills.
• Ability to work independently with good judgment and prioritization.
• Proficiency with computer-based systems including MS Office; LIMS experience preferred.

Responsibilities

• Manage equipment lifecycle activities, including maintenance strategies, instructions, calibration, metrology, troubleshooting, and technical support.
• Author, review, approve, retain, and maintain cGMP technical documentation.
• Perform data entry, documentation review, and Second Person Verification (SPV).
• Lead or support deviations, investigations, audits, and regulatory inspections.
• Identify continuous improvement opportunities and participate in lab projects.
• Train, mentor, and provide technical guidance to staff.

Skills

Maintenance

Troubleshooting

GMP

Documentation

Teamwork

Leadership

Independent Work

MS Office

LIMS

CMMS

ELN

Tools

LIMS

CMMS

ELN

Job description

This position serves a local pharmaceutical company in downtown Indianapolis, and it is as secure as most direct-hire positions. It is a new position open due to CREW's reputation!

It is NOT a short-term or multi-year contract position! As with almost all CREW’s positions, it is an executive-approved need for long-term, on-going support. As a point of reference, 72% of our employees have been with us for two or more years, and 40% of our employees have been with CREW five years or more. The position is as secure as most direct-hire positions, really!

In this position you will maintain and repair QC Chemistry and Microbiology equipment across 5 labs in an RLT (Radioligand Therapies) environment. Apply technical expertise to perform scheduled preventative maintenance and equipment repair. Work with outside vendors and internal lab customers to ensure quality, efficiency, and regulatory compliance. You will also assist as needed with system, process, and corporate migration.

Must-have Requirements:

• Proven ability in maintenance, repair, complex instrumentation, and troubleshooting. Preferred experience in laboratory operations and/or analytical equipment.
• Proven experience in a regulated GMP environment. Preferred in pharmaceutical or medical environment.
• Demonstrated scientific, technical, documentation, and/or data integrity knowledge, including a working knowledge of applicable policies, procedures, and guidelines.
• Strong teamwork, interpersonal, written, and verbal communication skills, with the ability to mentor colleagues and provide leadership as needed.
• Proven ability to work independently, exercise sound judgment, prioritize responsibilities, manage multiple tasks, maintain attention to detail, and resolve problems effectively.
• Proficiency with computer-based systems and software applications, including Microsoft Office, Microsoft Teams. Preferred experience in LIMS.
• Ability to perform work safely and effectively in a highly regulated environment, including proper use of required personal protective equipment and safety equipment.

Additional Strong Preferences:

• Experience with electronic notebook (ELN) and computerized maintenance management systems (CMMS).
• Experience with deviation and change control processes.
• Experience troubleshooting and maintenance on various LC instruments.

Position Tasks:

• Manage equipment lifecycle activities, including maintenance strategies, work instructions, qualification protocols, calibration, metrology, troubleshooting, and technical support for equipment and methods.
• Author, review, approve, retain, and maintain cGMP technical documentation, including procedures, validation protocols, change controls, analytical investigations, and quality system records.
• Perform data entry, documentation review, and Second Person Verification (SPV) in accordance with applicable procedures, standards, GMP requirements, and data integrity expectations.
• Lead or support deviations, observations, non-routine investigations, self-assessments, regulatory inspections, and audits, including recognition and escalation of procedural departures.
• Identify and communicate continuous improvement opportunities, maintain and improve quality systems, share technical best practices, and participate in or lead laboratory projects.
• Train, mentor, and provide technical guidance while managing assigned performance and procedural notification responsibilities.