Manufacturing Engineer - Integrated Resources, Inc
Pompano Beach, FL 33069
About the Job
Job Title: Manufacturing Engineer
Job Location: Pompano Beach, FL
Job Duration: 12 Months
Job Description:
Quals--
Job Requirements:
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Job Location: Pompano Beach, FL
Job Duration: 12 Months
Job Description:
- 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 the 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 to provide updates as well as take away any actions.
- Performs related duties as assigned.
Quals--
Job Requirements:
- Experience of 1-3 years’ experience in a cGMP-regulated manufacturing environment or an equivalent combination of training and experience is required. 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.
- 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.
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Source : Integrated Resources, Inc