Quality Engineer - Biologics Manufacturing
Location : Princeton NJ US 08540
Job Type : Direct
Reference Code : 19276-AB1
Compensation : 100000.00 - 120000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 6
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Biotechnology
Job Description :
- Permanent position for a Quality Engineer to oversee Quality Assurance of biologics development, contract manufacturing, and quality control.
- Support Pharmaceutical Development, Technology Transfer, and product manufacturing.
- Conduct and oversee QA activities to support process and analytical risk assessments, clinical manufacturing, scale-up and qualification, and validation for drug substance, drug product, and analytical methods development.
- Responsible for QA review and approval of Validation master plans, qualification/validation protocols, and final reports for analytical methods, manufacturing, cleaning, equipment and facilities, and deviations and investigations.
- Material review and approval of product contact components and packaging materials.
- Travel to contract manufacturers to oversee product manufacturing, assisting with root cause analysis and impact assessment.
- Collaborates with analytical team to define and approve product specifications
- Identify and lead continuous Quality improvement projects.
- Responsible for Quality metrics management, analysis, and trending.
- Present report of manufacturing parameters, stability data, temperature excursions, deviations, and CAPAs.
- Follows all applicable regulatory requirements, cGMP guidelines, and industry guidance documents and Quality by Design (QbD) principles for biologics and manufacturing.
- Interface with QA management to develop best practice standards, Key Performance Indicators, training needs and resource utilization optimization.
- Up to 25% international and domestic travel.
Required Qualifications :
- BS Engineering or Science
- Minimum 6 years experience in Biologics manufacturing.
- Comprehensive hands-on knowledge of biologics manufacturing, deviations, validation, and conducting risk-assessments.
- In-depth knowledge of current Good Manufacturing Practices, Quality System regulations, ISO standards, and Quality by Design(QbD).
- Demonstrated experience to support new and on-going product development and manufacturing of biologics.
- ASQ CQE/CQA or Lean Six Sigma certification preferred.
- Experience with process and analytical qualification/validation.
- Detail oriented, self-starting, well organized with strong problem solving, project management, interpersonal, communication and presentation skills.
Contact: Allan Berman