Manufacturing Engineer

JobSquad Staffing Solutions; Rosenberg (TX); On-site; USD 95,000 - 135,000; Full time

Job summary

JobSquad Staffing Solutions seeks a hands-on pharmaceutical manufacturing engineer to work on the production floor in a fast-paced environment. You will collaborate with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D to troubleshoot equipment and processes, identify root causes, and implement sustainable improvements.

The ideal candidate has direct pharma manufacturing engineering experience, especially with liquids and/or semi-solid products, and will be comfortable on the

Qualifications

• Bachelor's degree in Mechanical, Chemical, Industrial, Manufacturing, Electrical Engineering, or a related engineering discipline.
• 3-5+ years of pharmaceutical manufacturing engineering experience, with preference for 5+ years.
• Strong knowledge of FDA requirements, cGMP, and regulated pharmaceutical manufacturing practices.
• Direct experience with semi-solid products such as creams, ointments, and suppositories and/or liquid products, including solutions and suspensions.
• Hands-on experience troubleshooting manufacturing and packaging equipment to reduce downtime and improve equipment reliability.
• Experience with equipment installation, commissioning, startup, qualification, and validation.
• Experience with IQ/OQ/PQ, process validation, and cleaning validation.
• Experience with deviations, Root Cause Analysis (RCA), CAPA, and change control.
• Must be comfortable spending significant time on the manufacturing floor supporting day-to-day operations.

Skills

Pharma manufacturing

Production floor troubleshooting

Root Cause Analysis

CAPA

Education

Bachelor's degree in Mechanical/related engineering

Tools

SAP

Job description

This is a hands-on, floor-oriented engineering position within a pharmaceutical manufacturing environment. The individual will work closely with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D. Ideal Candidate:

Our strongest candidate will have direct pharmaceutical manufacturing engineering experience, particularly involving liquids and/or semi-solids. We are specifically looking for someone who is comfortable being on the production floor, troubleshooting equipment and processes, identifying root causes, and implementing sustainable improvements.

Key/Must-Have Qualifications:

• Bachelor's degree in Mechanical, Chemical, Industrial, Manufacturing, Electrical Engineering, or a related engineering discipline.
• 3-5+ years of pharmaceutical manufacturing engineering experience, with preference for candidates with 5+ years.
• Strong knowledge of FDA requirements, cGMP, and regulated pharmaceutical manufacturing practices.
• Direct experience with semi-solid products such as creams, ointments, and suppositories and/or liquid products, including solutions and suspensions.
• Hands-on experience troubleshooting manufacturing and packaging equipment to reduce downtime and improve equipment reliability.
• Experience with equipment installation, commissioning, startup, qualification, and validation.
• Experience with IQ/OQ/PQ, process validation, and cleaning validation.
• Experience with deviations, Root Cause Analysis (RCA), CAPA, and change control.
• Must be comfortable spending significant time on the manufacturing floor supporting day-to-day operations.

Strongly Preferred Experience:

• New Product Introduction (NPI), process scale-up, and technology transfer.
• User Requirement Specifications (URS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
• Experience improving throughput, productivity, labor efficiency, equipment reliability, and OEE.
• Demonstrated ability to reduce downtime and optimize manufacturing costs.
• Lean Manufacturing, Kaizen, Six Sigma, and 5S.
• Experience developing/revising SOPs and manufacturing work instructions.
• Experience supporting regulatory, customer, and internal audits.
• SAP or comparable ERP system experience.