The candidate will be on the manufacturing floor gathering feedback from the machine operators and other floor workers, to troubleshoot processing problems which may include instrumentation and machines, revise documents, collect data, conduct hazard reviews, and operator training.
The time in the office will be spent analyzing data, performing root cause analysis, document revisions, compiling and authoring periodic regulatory compliance reports, investigation/hazard review as well as review of equipment design and compliance requirements.
BS in Chemical, Biochemical or Mechanical Engineering. Will also consider Master's candidate.
Relevant experience in the pharmaceutical industry is preferred.
Thorough knowledge of cGMPs as well as chemical reaction and purification unit operations.
Knowledge of engineering documentation required for cGMP process equipment Document Revision/Creation Operator Training Incident Investigation Hazard Reviews Data Collection/Analysis.
The role is a level II, however, the candidate can be just out of college, or have co-op experience/internship.
1-2 years of experience preferred, but not required
Candidate should have excellent mechanical aptitude as well as top-notch Word/Excel skills.
Experience with API and SAP ECC Pharma industry experience cGMP and GMP experience
CAPA - Corrective and preventative actions experience is helpful.