Sr Associate

Aditi Consulting

Thousand Oaks (CA)

On-site

USD 33,000 - 34,000

Full time

14 days+

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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

Payrate: $23.50- $24.50/hr

Summary

In this vital role you will be part of the Manufacturing Technical Operations (MTO) Production Process Owner (PPO) team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug product supply organization in ATO Building 20 which is a dynamic environment and an important launch point for Client’s pipeline products. The plant manufactures drug product at all phases of clinical trials through commercial production.

Responsibilities

Support manufacturing by providing subject-matter expertise for drug product vial and syringe filling processes as production process owner (PPO)
Lead sophisticated projects or parts of projects using project management skills.
Resolve quick issues and execute function tests to troubleshoot and optimize process
Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
Demonstrate strategic problem-solving skills and champion continual improvement.
Ability to be on-site (flexible worker)
Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
Develop/own drug product manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
Support New Product introduction and projects through SUS mapping
Support manufacturing and quality through the SUS defect/leak triage process - perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
Understand single-use material capabilities and user requirements for new technologies.

Basic Qualifications

Master’s degree Or
Bachelor’s degree and 2 years of manufacturing and operations experience Or
Associate’s degree and 4 years of manufacturing and operations experience Or
High school diploma / GED and 6 years of manufacturing and operations experience

Top 3 Must Have Skill Sets

Project Management
Communication Skills
Willingness to Learn

Pay Transparency

The typical base pay for this role across the U.S. is: $23.50- $24.50/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages.