Senior GMP Manufacturing Process & Projects Specialist

Aditi Consulting; Thousand Oaks (CA); On-site; USD 33,000 - 34,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan participation

Life and disability insurance

Commuter benefits

Paid time off

Bonuses or recognition programs

Job summary

Aditi Consulting in Thousand Oaks, CA, seeks a Production Process Owner within the Manufacturing Technical Operations team. You will support vial and syringe filling, introduce new technologies, drive CAPA and deviation handling, and champion continuous improvement for a multiproduct drug product facility.

The role requires project management, GMP experience, and availability for on-site work in a clean room, with shift flexibility to align with production schedules and regulatory requirements.

Qualifications

• Master’s degree or equivalent in a relevant field.
• 2+ years of manufacturing and operations experience with a BS, or 4+ years with an AA.
• GMP/regulatory environment experience is desirable.

Responsibilities

• Support drug product vial and syringe filling processes as PPO.
• Lead projects or parts of projects using project management skills.
• Resolve quick issues and perform function tests to troubleshoot and optimize processes.
• Write validation protocols and reports for validation, testing, and change control.
• Own Quality Records such as CCMS, CAPA, and CAPA-EV.
• Work various shifts (day, swing, grave, weekends, holidays) as scheduled.
• Work in a clean room with PPE and GMP-compliant practices.
• Apply technical/process knowledge to implement new technologies in the plant.
• Develop/own drug product manufacturing processes and SOPs for new tech.
• Support SUS mapping for New Product Introduction and projects.

Skills

Project Management

Communication Skills

Willingness to Learn

Education

Master’s degree in a related field

Bachelor’s degree with 2+ years of manufacturing and operations experience

Associate’s degree with 4 years of manufacturing and operations experience

High school diploma / GED with 6 years of manufacturing and operations experience

Job description

Aditi Consulting in Thousand Oaks, CA, seeks a Production Process Owner within the Manufacturing Technical Operations team. You will support vial and syringe filling, introduce new technologies, drive CAPA and deviation handling, and champion continuous improvement for a multiproduct drug product facility.

The role requires project management, GMP experience, and availability for on-site work in a clean room, with shift flexibility to align with production schedules and regulatory requirements.