Process Validation​/Manufacturing Eng

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