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.

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 supporting regulatory, customer, and internal audits.
• Experience using SAP or a comparable ERP system.

$80000.00

$100000.00

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