Job Description
Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring an API Manufacturing Engineer.
Position Type:
- Contract
- On-Site
Required:
- Previous hands on experience in: API Manufacturing.
- Experience performing deviation investigations in GMP environments.
- Shop floor manufacturing experience.
- Strong root cause analysis and investigation skills.
- Good technical writing/documentation skills.
- Experience with CAPA activities.
- Experience supporting manufacturing/process troubleshooting.
Nice to Have:
- Quality Operations experience.
- QC chemistry lab experience.
- Aseptic manufacturing experience.
- Batch investigation experience.
- Backlog investigation remediation experience.
Responsibilities:
Main Responsibilities:
- Lead deviation investigations from initiation to closure.
- Perform root cause analysis using tools such as:
- o 5 Why
o Fishbone
o 6M
o Cause & Effect Analysis - Write clear and well documented investigation reports.
- Support CAPA definition, implementation and effectiveness checks.
- Support backlog investigation remediation activities.
- Work closely with Manufacturing, QA, QC and technical teams during investigations.
- Update SOPs and GMP documentation when required.