Process Validation/Manufacturing Eng needs 1-3 years experience in a cGMP-regulated manufacturing environment or an equivalent combination of training and experience is required.
Process Validation/Manufacturing Eng requires:
Bachelor's degree in engineering or a related field of specialization.
Industrial engineering is preferred, but not required.
Process Validation
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements.
Speak and write fluent English with proficiency in technical writing for complex reports and regulatory documents
Process Validation/Manufacturing Eng duties:
Interpret specifications, standard operating procedures, and standard testing procedures
Works as a member of a team to achieve all outcomes
Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)
Performs assessments/approvals of change controls related to production activities