Manufacturing Engineer

Title: Manufacturing Engineering /Validation

Location: Pompano Beach FL

Duration: 12 Months

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 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.

Skills Required:

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

Comments/Special Instructions

Please be advised. Candidates need to have experience in Quality Assurance and Validation procedures. Must have keywords like, protocol experience, drafting, and execution. This position is mainly concentrated on validation documents, change control, and CAPA analysis.

Job Type: Contract

Salary: $37.21 - $44.82 per hour

Experience level:

• 10 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: On the road