• Process Engineer / Scientist Jobs in United States Of America

  • Pfizer Inc.
  • United States Of America, Usa

Job Description:

ROLE SUMMARY

The Process Engineer/Scientist in manufacturing operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance Additional roles include using operational and technical knowledge to perform troubleshooting activities, assist with tech transfer and start-up activities, provide investigations support, analyze process data, and identify and implement moderate process improvements

ROLE RESPONSIBILITIES

Execution of relevant process activities including protein purification operations (depending on the background of the candidate), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOPs
Setup and evaluation of unit operations, executions, and changeover (daily and long-term)
Troubleshooting of moderately complex process disturbances, identifying resolution and implementing corrective and preventive measures, as require
Real time assessment of process performance
Individual will be required to perform process monitoring, data analysis, and data preparation for presentation in several forums including project team meetings
Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables and review applicable documentation
Provide input for process overview presentations, sampling plans, and other tech transfer deliverables
Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust and capable solution
Individual will help to ensure the equipment and facilities are maintained in a GMP compliant state at all times
The individual will be responsible for collaborating within the department as well as other departments to communicate and coordinate activities
Individual will assist in inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment
Individual will be responsible for modifying and/or creating job related documentation
Individual will assist in the evaluation and implementation of new technology for process execution and/or analysis
Individual will be expected to participate and drive in continuous improvement and innovation initiatives Individual is expected to be an M1 lead
Individuals are responsible to ensure a safe work environment and to lead job hazard analysis opportunities
Individuals will be required to display multi-tasking skills
Identifies the need for escalation and/or remediation with various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance

BASIC QUALIFICATIONS

Bachelors degree in Engineering (Chemical preferred) is required or
Bachelors degree in Life Sciences with minimum 2 years of experience is required

PREFERRED QUALIFICATIONS

Experience in a biopharmaceutical environment is preferred

PHYSICAL/MENTAL REQUIREMENTS

Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs
Must have the ability to lift ~50 pounds
The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals
The incumbent is required to attain detail knowledge of the operational equipment
The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing
The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc

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
Pfizer Incarfix

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