Harba Solutions Inc.
Job Responsibilities
Support continuous improvement and capital projects to enhance equipment reliability, process robustness, and overall manufacturing efficiency within a GMP-regulated environment.
Provide engineering support for pharmaceutical production systems, including troubleshooting, process optimization, scrap and deviation reduction, and equipment capacity improvements.
Lead cross-functional project teams to implement lean manufacturing initiatives that drive productivity, improve product quality, strengthen process control, and ensure regulatory compliance.
Identify, prioritize, and execute improvement projects based on risk assessment, process impact, and alignment with operational and quality objectives.
Conduct root cause investigations in support of CAPA processes; document findings, propose and implement corrective measures, and verify long-term effectiveness.
Author, review, and maintain SOPs related to equipment operation, cleaning, setup/changeover, and preventive maintenance to ensure accuracy and compliance with current GMP standards.
Collaborate with vendors and internal stakeholders to define system specifications, obtain quotations, and support equipment procurement and qualification activities.
Develop and manage project timelines, ensuring alignment with production schedules and quality requirements.
Write, review, and execute validation documentation, including PVPs, IQ, OQ, PQ, as well as risk-based assessments such as FMEA and Risk Analyses (RA).
Maintain a thorough understanding of cGMP, ISO 13485, and applicable FDA/EMA regulations governing pharmaceutical manufacturing and equipment validation.
Support routine operations by diagnosing and resolving equipment or process deviations in collaboration with Maintenance, Quality, and Manufacturing teams.
Qualifications
Bachelor’s degree (or equivalent) in Biomedical, Mechanical, Chemical, or Manufacturing Engineering or related technical fields
3+ years of experience in a pharmaceutical, biopharmaceutical, or regulated manufacturing environment.
Hands-on experience with IQ/OQ/PQ, FMEA, risk assessments, and validation documentation preferred.
Strong understanding of cGMP, equipment qualification, and process validation principles.
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Support continuous improvement and capital projects to enhance equipment reliability, process robustness, and overall manufacturing efficiency within a GMP-regulated environment.
Provide engineering support for pharmaceutical production systems, including troubleshooting, process optimization, scrap and deviation reduction, and equipment capacity improvements.
Lead cross-functional project teams to implement lean manufacturing initiatives that drive productivity, improve product quality, strengthen process control, and ensure regulatory compliance.
Identify, prioritize, and execute improvement projects based on risk assessment, process impact, and alignment with operational and quality objectives.
Conduct root cause investigations in support of CAPA processes; document findings, propose and implement corrective measures, and verify long-term effectiveness.
Author, review, and maintain SOPs related to equipment operation, cleaning, setup/changeover, and preventive maintenance to ensure accuracy and compliance with current GMP standards.
Collaborate with vendors and internal stakeholders to define system specifications, obtain quotations, and support equipment procurement and qualification activities.
Develop and manage project timelines, ensuring alignment with production schedules and quality requirements.
Write, review, and execute validation documentation, including PVPs, IQ, OQ, PQ, as well as risk-based assessments such as FMEA and Risk Analyses (RA).
Maintain a thorough understanding of cGMP, ISO 13485, and applicable FDA/EMA regulations governing pharmaceutical manufacturing and equipment validation.
Support routine operations by diagnosing and resolving equipment or process deviations in collaboration with Maintenance, Quality, and Manufacturing teams.
Qualifications
Bachelor’s degree (or equivalent) in Biomedical, Mechanical, Chemical, or Manufacturing Engineering or related technical fields
3+ years of experience in a pharmaceutical, biopharmaceutical, or regulated manufacturing environment.
Hands-on experience with IQ/OQ/PQ, FMEA, risk assessments, and validation documentation preferred.
Strong understanding of cGMP, equipment qualification, and process validation principles.
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