Process Engineer

Local to south Florida candidates only

Out of state candidates will not be considered

Our client is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. With a parent company who is the largest manufacturer of pharmaceutical products (in their field) in the world, you will be working in an FDA approved, state-of-the art manufacturing facility in Miami, FL.

This is a contract – to – permanent opportunity (based on performance) and the pay rate is $24 – $26 an hour. If you are extended a permanent offer the salary could range between $55 to $60K with excellent benefits.

As a Process Engineer you assist in process development activities of new products for non-clinical to commercialization with adherence to Current Good Manufacturing Practices (cGMPs). Gather data from Design of Experiments (DOEs) and provide statistical analysis in assessing process performance. Perform calculations of DEA controlled substances.

Essential Functions:

• Assist in the development and coordination of experiments, including but not limited to DOEs to characterize and improve processes.
• Assist in process development for blending, coating, slitting and packaging of new products for Product Development.
• Compile data from DOEs and provide statistical analysis in assessing process performance.
• Perform drug calculations for controlled substances.
• Develop protocols, batch records, procedures to ensure successful project execution.
• Apply cGMPs as related to process design to ensure FDA compliance.
• Assist during product/process design and re-design in an effort to reduce costs to optimize technology transfer.
• Interface with Engineering, Validation, Production, and customers to troubleshoot production processes and equipment issues.
• Perform special projects as required.
• Meet medical requirement for personal protective equipment (PPE) used during manufacturing.

Job Requirements

• BS degree with five to ten years of relevant pharmaceutical experience required.
• Knowledge of manufacturing processes steps and quality standards.
• Knowledge of Six Sigma and statistical tools.
• Ability to ascertain that work complies with approved Standard Operating Procedures and meets all guidelines
• Good written and verbal communication skills; highly organized.
• Candidate must demonstrate computer skills with knowledge of office applications software, Mini Tab and enterprise software, attention to detail, ability to speak, read and writes in the English language.
• The employee must demonstrate the ability to perform statistical analysis using Mini Tab.
• Employee must demonstrate the ability of adhering to stringent cGMP and DEA documentation requirements.
• Employee must have good interpersonal skills to interface with other internal groups.

Salary: $50,000.00 to $55,000.00 /year

Job Location:

• Miami, FL

Required education:

• Bachelor’s

Required experience:

• Process Development in a Pharmaceutical Environment: 5 years
• cGMP and FDA Compliance: 5 years
• DOE: 5 years