Manufacturing Engineer

Yoh Life Sciences is seeking an experienced Manufacturing Engineer to join a pharmaceutical manufacturing organization in Rosenberg, TX. This is a hands-on, floor-oriented engineering position supporting day-to-day pharmaceutical manufacturing operations.

The Manufacturing Engineer will work closely with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D to troubleshoot equipment and process issues, improve manufacturing performance, support new product and equipment initiatives, and ensure compliance with FDA and cGMP requirements.

The ideal candidate will have direct pharmaceutical manufacturing engineering experience, particularly with liquid and/or semi-solid products, and be comfortable spending significant time on the manufacturing floor.

#IND-SPG

Estimated Min Rate
: $80000.00

Estimated Max Rate
: $100000.00

Manufacturing Engineer

Rosenberg, TX

Direct Hire

Monday–Friday, 8:00 AM–5:00 PM

$80, annually

• Provide hands-on engineering support to pharmaceutical manufacturing operations.
• Troubleshoot manufacturing and packaging equipment issues to minimize downtime and improve equipment reliability.
• Support equipment installation, commissioning, startup, qualification, and validation activities.
• Develop and execute engineering and validation documentation, including IQ/OQ/PQ.
• Support process validation and cleaning validation activities.
• Investigate manufacturing deviations and perform Root Cause Analysis (RCA).
• Develop and implement CAPA and change controls.
• Identify and implement opportunities to improve throughput, productivity, labor efficiency, equipment reliability, and Overall Equipment Effectiveness (OEE).
• Support manufacturing process improvements and cost-reduction initiatives.
• Collaborate cross-functionally with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D teams.
• Develop and revise SOPs, manufacturing procedures, and work instructions.
• Support regulatory, customer, and internal audits.
• Ensure engineering and manufacturing activities comply with applicable FDA, cGMP, safety, and quality requirements.

• 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 manufacturing 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.
• Experience with equipment installation, commissioning, startup, qualification, and validation.
• Working knowledge of IQ/OQ/PQ, process validation, and cleaning validation.
• Experience with deviations, Root Cause Analysis (RCA), CAPA, and change control.
• Ability and willingness to spend significant time on the manufacturing floor supporting daily operations.
• Strong analytical, troubleshooting, communication, and problem-solving skills.

• Experience with New Product Introduction (NPI), process scale-up, and technology transfer.
• Experience developing User Requirement Specifications (URS).
• Experience with Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Proven success improving throughput, productivity, labor efficiency, equipment reliability, and OEE.
• Demonstrated ability to reduce downtime and optimize manufacturing costs.
• Experience with Lean Manufacturing, Kaizen, Six Sigma, and 5S methodologies.
• Experience developing and revising SOPs and manufacturing work instructions.
• Experience…