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Almac Group · 11 hours ago

Calibration Technician

Souderton, PA

Full-time

Onsite

Mid Level

3+ years exp

Almac Group is an exceptional, award-winning drug development solutions provider at the forefront of the pharmaceutical industry. They are seeking a Calibration Coordinator responsible for scheduling, coordinating, executing, and documenting calibration activities while ensuring GxP regulatory compliance is maintained across business units.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Hiring Manager

Taylor Clauss

Responsibilities

Coordinate daily calibration activities within a GxP regulatory environment to maintain a high level of support to each Almac Business Unit. Through collaboration with area process owners, schedule instrumentation calibrations into operations with the objective of minimizing downtime while ensuring calibrations are completed and documented in compliance with relevant SOPs and to GxP standards

Execute the calibration operation phase activities including planned and unplanned calibration work orders carried out internally or by contracted service providers ensuring the work orders are completed and approved by the due date. Review and approve calibration certificates ensuring certificates are accurately aligned with the work orders and calibration labels have been applied. Provide immediate notification to the process owner for out of tolerance findings

Assist with the calibration project phase of instrument integration including critical risk assessment processes, instrument identification, instrument tagging, and supporting documentation. Assist with information collection that can be leveraged into the Master Calibration List

Provide calibration contracted service provider with the technical guidance required to accurately integrate instrumentation through the project phase and the operation phase of the calibration management process. Ensure the contractor is trained and complies with all SOPs and GxP standards required by each Almac Business Unit

Ensure that all calibration schedules are upheld and that all calibrations are completed prior to their due date

Ensure calibration labels are applied to instrumentation and are accurately aligned with the calibration certification and work order

Provide immediate notification for out of tolerance or other instrument deviations to the process owner

Coordinate the HEPA filter testing and other associated certifications into the Almac operational schedule ensuring the work orders and certification are completed and approved prior to the due date

Provide the required support of commissioning and decommissioning activities as defined with the calibration management process

Coordinate the company approved calibration contractors into the Almac Business Unit’s operational schedule while minimizing downtime

Ensure that all contractors and vendors are properly escorted, trained and remain compliant while performing calibration activities

Maintain a compliant status of the positions training curricula

Achieve a thorough understanding of all relevant policies and SOPs within the Company, ensuring that approved contractors adhere to all relevant SOPs and properly complete associated documentation and training records

Conform to safety guidelines and regulations to guarantee safe work practices of Almac staff and clients

Provide updates on critical issues to your line manager

Maintain good working relationships within Almac and its business units

Provide calibration support during scheduled equipment shutdowns or other activities required during non-business hours

Implementation of accurate, effective, and resourceful calibration support to the business units

Support calibration documentation requests during customer and regulatory audits performed on site

Qualification

Calibration within GxP/ISOGxP DocumentationTechnical training in electronicsCalibration practicesBuilding monitoring systemsMicrosoft ProductsPharma/BioTech/Life SciencesElectronic theoryAC/DC conceptsPractical multi-meter useUnderstanding of electricityCalibration theoriesPrinciples

Required

High School Diploma or equivalent required

Technical training through a certified technical institution in electronics or instrumentation

3+ years Calibration within a GxP/ISO environment

1+ year GxP Documentation

A thorough understanding of the technical details related to environmental instrumentation, test points, tolerances, and accuracy

Calibration practices

Building monitoring systems

GxP practices

Intermediate/advanced knowledge of calibration theories and principles

Practical multi-meter use

Intermediate understanding of electricity (AC/DC theory)

Intermediate Microsoft Products

Preferred

Associates Degree or certification in a Specialized Technology field

Pharma/BioTech/Life Sciences work experience

Electronic theory

AC/DC concepts

Windows 7.0 / 10.0 operating systems

Calibration Practices

Benefits

Medical, Vision & Dental benefits from the 1st of the month following start date

20 days PTO per year, accrued monthly following start date

12 holidays per year as well as one day for Annual Diversity Day

Company paid Long and Short-term disability along with Life Insurance

401k company contribution

Professional development programs/ continuous learning opportunities

Company

Almac Group

Glassdoor3.7

Almac Group is a contract development and manufacturing firm offering integrated services to pharmaceutical and biotech companies globally.

Founded in 2002

Craigavon, Craigavon, GBR

5001-10000 employees

https://www.almacgroup.com

H1B Sponsorship

Almac Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)

2021 (1)