Manufacturing Engineering Technician

Job Responsibilities:
Interfaces with Quality Assurance Production and Engineering departments on process requirements for new and current products.
Equipment qualification including automation and computerized systems.
Writes and executes evaluation protocols for all processing steps.
Analyzes and interprets protocols to prepare additional documentation to support project.
Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
Prepare / edit all types of documentation (batch records SOPs protocols summary reports etc.)
Writes final reports and assures they are approved through proper channels.
Trains Production and Quality Assurance personnel as required.
Attends Daily Meetings so as to provide updates as well as take away any actions.
Performs related duties as assigned.

Skills 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 a proficiency in technical writing for complex reports and regulatory documents.
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

Job Requirements:
Sound experience in a cGMP regulated manufacturing environment or an equivalent
combination of training and experience is required.
Bachelors degree in engineering or a related field of specialization.
Industrial engineering preferred but not required.