Technical Operations Engineer
Technical Operations Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
- Provides support in manufacturing activities during the technology transfer qualification and validation batches associated with new product introductions to the site.
- Provides technical expertise related to manufacturing process and equipment in response to deviations and design of experiment to understand and eliminate the root cause(s).
- Support investigations from chemistry/process perspective for product complaints and deviations.
- Identify and develop necessary laboratory experiment for continuous improvement projects. Work closely with process engineers and other departments to deliver these continuous improvement projects including change control management.
- Participate in PHA and quality risk assessment activities providing relevant technical knowledge related to process chemistry and safety.
- Actively participate to collaboration and learning of best practices with external subject matter experts (SMEs) including GPRD MS&T on process development for suitable future product introduction.
- Provides support to regulatory filings and cGMP audit activities.
- Authors technical reports batch records SOPs investigations protocols as required and ensures consistency and quality of the groups documentation in compliance with company guidelines.
- Any other duties as assigned by supervisor.
Qualifications :
- Bachelors/Masters/PhDs degree In a technical/science field including Chemistry Biochemistry or Pharmaceutical Sciences.
- 06 years (bachelor)/04years (Master)/02 year (PhD) technical experience in process chemistry pharmaceutical manufacturing process tech transfer commissioning and validation in pharmaceutical industry.
- Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is preferred.
- Demonstrated process development skills including the ability to deliver innovative process chemistry at scale.
- Proven records in facilitating the successful transition from laboratory to full scale production.
- Experience of startups and new product introduction to commercial facilities is preferred.
- Good problem solving skills embrace problem solving tools like FMEA 5 Why able to work under pressure and tight timeline.
- Team player highly selfmotivated and able to work under minimum supervision.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
US & Puerto Rico only to learn more visit ;
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
