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Equipment Engineer

1 month ago

Malvern, United States Insight Global Full time

Title: ELM Qualification Analyst

Schedule: Monday – Friday, flex on schedule – can start between 7-9am (40 hour work week)

Location: Malvern PA – fully onsite to start, room to move to hybrid a few months down the line with 2 days remote

Duration: 1 year, will most likely continue to renew

Team: 5 total people, this position will be the 6th

Reason for opening: Increase in work / labs opening + changes in management

Training duration: 3-6 months, 6 months they will be working on projects independently

Interviews: 1 and done, virtual or onsite

BR: 80-100/hr

PR: 30-35 for junior, 40-50 for experienced

Requirements:

-Bachelor degree in Scientific field

-Minimum 2 years of experience working within a QC GMP environment with troubleshooting exposure of equipment

-Excellent GMP understanding

-Technically proficient in understanding GMP instrumentation

-Strong experience utilizing Microsoft Office

-Go-getter personality with team-oriented mindset

Preferred:

-Software experience with Empower SAP Sustain, SAP Meridian Cloud, Track wise

-Experience with technical writing – writing protocols and procedures, validation documentation

Day to Day: One of our large pharmaceutical clients is looking to hire an Qualification Analyst for the Equipment Lifecycle Management team within the Quality department. This individual will be responsible for following Quality Control procedures on the installation, qualification, and maintenance of GMP analytical instruments in Clinical Release & Stability labs.

Responsibilities will include:

-Leading and participating in cross-functional teams.

-Communicating with vendors to coordinate maintenance and troubleshooting activities.

-Must follow Good Documentation practices.

-Draft and execute instrument qualification protocols, site operating procedures, and other technical documents with minimal guidance once trained on internal processes.

-Draft protocols, supporting documents, and procedures for new instruments and equipment.

-Write and execute QC analytical equipment qualifications

-Connect with QA to follow up on investigations to understand the root cause

-Overall Equipment lifecycle management


Compensation:

$30/hr to $40/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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