Manufacturing Specialist

Planet Pharma; Thousand Oaks (CA); On-site; USD 34,000 - 48,000; Full time

Job summary

Planet Pharma is seeking an experienced Process Owner to support Drug Substance Upstream and Downstream manufacturing. You will lead cross-functional projects, troubleshoot issues, and generate validation and change-management documentation.

This role requires strong GMP knowledge and the ability to write clear protocols and reports. The candidate will own Quality Records, drive continual improvement, and supervise multiple shifts as needed in a clean-room environment.

Qualifications

• Bachelor-level degree inEngineering or Life Sciences.
• Experience in Drug Substance GMP technical support roles or related fields.
• Strong written and verbal communication for diverse audiences.

Responsibilities

• Support manufacturing as Process Owner for Drug Substance Upstream and Downstream processes.
• Lead cross-functional projects and troubleshoot production issues.
• Write protocols and reports for validation, testing, commissioning, and change management.
• Own Quality Records (CCMS, CAPA, CAPA-EV) and ensure GMP compliance.
• Develop user requirements for new technologies and document GMP procedures.
• Influence teams through data-driven problem solving and milestone delivery.
• Communicate complex technical information to varied audiences.

Skills

Process ownership

Project management

Technical troubleshooting

Technical writing

Quality Records

GMP compliance

Cross-functional collaboration

Education

Degree in Engineering or Life Sciences

Tools

Smartsheet

Excel

Trackwise

Visio

PI

SAP

Spotfire

Job description

Target PR Range: 25-35/hr DOE

Responsibilities include:

• Support manufacturing by providing subject-matter expertise for Drug Substance Upstream and Downstream processes as Process Owner (PPO).
• Lead cross-function and complex projects using project management skills.
• Resolve quick issues and lead troubleshooting, including execution of 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.
• 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.
• 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.

Ability to be on-site (flexible worker)

• As Process owner:
• 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 substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms).
• Draft and develop user requirements for new technologies.

Preferred Qualifications

• Degree in Engineering or Life Sciences
• 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to navigate through ambiguity and identify and deliver on key milestones.
• Ability to advise and influence using experience and data.
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach and/or cross train colleagues within core technical area.
• Team player – Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
• Ability to drive results through leadership of cross-functional teams
• Experience leading and managing projects
• Understanding of single-use technologies
• Data analysis and/or data visualization skills
• Excellent writing skills. Presentation experience – presentation to leadership or auditors.
• Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, spotfire