Overview
On Site
$50+
Full Time
Skills
Process
Manufacturing
Job Details
Write protocols, reports, procedures and memos as needed to support Adjuvant
manufacturing activities related to engineering, investigational, definition, development
and process validation runs
Support execution and documentation of engineering, development and/or validation
studies and lead or supervise groups and/task force in the planning of engineering,
investigational, definition, development and process validation runs.
Input to design space / DOE studies through establishment of scale-up / scale-down
parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling,
dimensionless parameters, etc.) and process control strategies.
Provide technical assistance to manufacturing and quality operations for process
troubleshooting, improvement, technical transfer and health authority inspections to
achieving site metrics (+QDCI).
Fosters relationships with partners and customers in order to achieve technical
objectives.
manufacturing activities related to engineering, investigational, definition, development
and process validation runs
Support execution and documentation of engineering, development and/or validation
studies and lead or supervise groups and/task force in the planning of engineering,
investigational, definition, development and process validation runs.
Input to design space / DOE studies through establishment of scale-up / scale-down
parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling,
dimensionless parameters, etc.) and process control strategies.
Provide technical assistance to manufacturing and quality operations for process
troubleshooting, improvement, technical transfer and health authority inspections to
achieving site metrics (+QDCI).
Fosters relationships with partners and customers in order to achieve technical
objectives.
BS or MS in basic sciences, math, engineering or pharmacy with 2+ years experience in
biological processes or analytics in a cGMP environment.
Proficient with structured methodologies such as Good Engineering Practices, Quality by
Design, Design Space, & Process Control Strategies to be employed in the course of
industrial process design, validation and control.
Excellent written and oral communication skills.
Ability to work in cross functional teams, provide strong analytical skills for
troubleshooting and root cause analysis, and communicate with internal and external
team members.
Experience in equipment start-up, qualification and validation is preferred.
Proficiency with PI
Prior experience preparing and executing process performance qualification documents
biological processes or analytics in a cGMP environment.
Proficient with structured methodologies such as Good Engineering Practices, Quality by
Design, Design Space, & Process Control Strategies to be employed in the course of
industrial process design, validation and control.
Excellent written and oral communication skills.
Ability to work in cross functional teams, provide strong analytical skills for
troubleshooting and root cause analysis, and communicate with internal and external
team members.
Experience in equipment start-up, qualification and validation is preferred.
Proficiency with PI
Prior experience preparing and executing process performance qualification documents
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