• Manufacturing Associate or Senior Manufacturing Associate, Downstream Jobs in United States Of America

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 18 - 21 Years
  • Posted : 27 days ago

Job Description:

Executes, with oversight of qualified staff, complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring

Executes independently with adequate training fundamental operations

CIP/SIP of tanks, transfer lines, and process equipment

Buffer preparation and transfer into tanks and disposables

Performs In process testing for samples eg spectrophotometry, pH, conductivity, and maintenance of analytical equipment

This may include parts cleaning and weigh and dispense

Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies

Documents work according to cGMP and cGDP

Adheres to established regulations and follows cGMP established by site

Reports abnormalities and deviations in a timely and accurate manner

Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately

Maintains production areas according to predefined standards (5s)

Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification

Contributes to Quality activities as investigations and area walk-throughs

Manufacturing Associate Requirements

High school degree plus minimum one (1) year work experience in GMP regulated industry

Associates/Bachelors degree from an accredited institution or biotechnology vocational training preferred

One (1) or more years of experience in cGMP regulated industry

Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset

Strong written and verbal communication skills

Ability to work with computer-based systems and ideally experience with process control systems (eg Delta V) and manufacturing execution systems (MES)

Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards

Ability to work as part of a high performing team and collaborate effectively with staff

Basic knowledge of fundamental manufacturing concepts is preferred Does not require extensive technical knowledge of manufacturing operations

Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies

Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice

Senior Manufacturing Associate Requirements

High school degree plus minimum two (2) years work experience in GMP regulated industry

Associates/Bachelors degree from an accredited institution or biotechnology vocational training preferred

Two (2) or more years of experience in cGMP regulated industry

Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset

Strong written and verbal communication skills

Ability to work with computer-based systems and ideally experience with process control systems (eg Delta V) and manufacturing execution systems (MES)

Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards

Ability to work as part of a high performing team and collaborate effectively with staff

Strong working knowledge of fundamental manufacturing concepts is required Moderate technical knowledge of biologics operations is preferred

Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies

Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice

Eligibility Requirements

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

Who We Are

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Company
Boehringer Ingelheim India Pvt Ltdarfix

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