Regulated Manufacturing Specialist - Process Improvement

BCforward; United States; Sur place; USD 52 000 - 62 000; Plein temps

Résumé du poste

BCforward is seeking a Manufacturing Specialist to support manufacturing operations, process improvements, technical changes, compliance, and production reliability in a regulated environment.

The ideal candidate will have experience in pharmaceutical, biologics, life sciences, or other regulated manufacturing settings with knowledge of aseptic operations, process troubleshooting, deviations, CAPA, and root cause analysis.

Qualifications

• Bachelor's degree in Life Sciences, Physical Sciences, Engineering, or related field, or equivalent experience.
• Experience in manufacturing, process engineering, or technical operations.
• Experience troubleshooting process issues and supporting continuous improvement initiatives.
• Knowledge of aseptic processing, quality systems, regulatory compliance, or regulated manufacturing environments.
• Experience with deviations, Root Cause Analysis, CAPA, remediation, or structured problem-solving.
• Strong written and verbal communication skills with cross-functional teamwork.

Responsabilités

• Support manufacturing readiness, product transfers, new equipment start-up, process design, engineering runs, documentation, and equipment setup.
• Drive process improvements focused on quality, process capability, reliability, operational efficiency, and standard work.
• Provide technical support to manufacturing operations and assist with troubleshooting process-related issues.
• Manage Planned Events, CAPAs, deviations, corrective actions, and other manufacturing compliance activities.
• Lead or facilitate Root Cause Analysis and structured problem-solving investigations to identify causes and prevent recurrence.
• Review and support manufacturing documentation, quality records, training materials, process changes, engineering changes, and validation activities.
• Collaborate with Manufacturing, Quality, Engineering, and cross-functional teams to implement technical changes and process improvements.

Connaissances

Troubleshooting

Cross-functional collaboration

Communication skills

Formation

Bachelor's degree in Life Sciences/Engineering

Description du poste

BCforward is seeking a Manufacturing Specialist to support manufacturing operations, process improvements, technical changes, compliance, and production reliability in a regulated environment.

The ideal candidate will have experience in pharmaceutical, biologics, life sciences, or other regulated manufacturing settings with knowledge of aseptic operations, process troubleshooting, deviations, CAPA, and root cause analysis.