ZipRecruiter

Log In

1

Capa Project Manager Jobs in California (NOW HIRING)

System One

Project Engineer III

Fremont, CA · On-site

$90 - $100/hr

Owner of change control, deviation and CAPA. * Capable to lead projects (CAPEX or CI). * Capable of balance conflicting priorities and agile to manage changing priorities. * Ability to establish ...

CelLink Corp

EHS Manager

San Carlos, CA · On-site

$100K - $135K/yr

As the Manager, R&D Quality Audits, Inspections and CAPA, you will serve as a primary quality and compliance partner for assigned Kite R&D groups, studies, projects and locations. This role supports ...

Predicine, Inc

Manager, NGS Lab

Hayward, CA · On-site

... projects. The ideal candidate combines strong NGS technical expertise, people leadership, and ... CAPA, and reprocessing decisions.10% Compliance & Regulatory Readiness -- Ensure laboratory ...

Predicine

Manager, NGS Lab

Hayward, CA · On-site

... projects. The ideal candidate combines strong NGS technical expertise, people leadership, and ... Experience with assay validation, technology transfer, CAPA, audits, and regulatory inspections

Sandoz Group AG

... actions (CAPA commitments). * Maintain inspection readiness at all times to minimize findings ... Pharmacovigilance. * Project Management. * Reporting. * Safety Science. * Team Management.

Sila

Capital Projects, Quality Manager

Alameda, CA

$151K - $191K/yr

... project stakeholders. * Defect Management: Manage Non-Conformance Reports (NCRs) and develop Corrective and Preventive Actions (CAPA) to resolve quality risks before they impact timelines.

previous page

Showing results 41-60

All JobsCapa Project JobsCapa Project Manager JobsCapa Project Manager Jobs in California

Capa Project Manager information

What is a CAPA Project Manager?

CAPA Project Managers are professionals responsible for overseeing Corrective and Preventive Action (CAPA) projects within organizations, particularly in regulated industries like pharmaceuticals, medical devices, and manufacturing. Their main role is to ensure that issues identified during audits, inspections, or routine operations are effectively investigated, and actionable steps are taken to prevent recurrence. They coordinate cross-functional teams, manage timelines, and ensure that all CAPA processes comply with regulatory requirements. CAPA Project Managers also document findings, monitor progress, and report on the effectiveness of implemented actions.

How does a CAPA Project Manager typically collaborate with cross-functional teams during the corrective and preventive action process?

As a CAPA Project Manager, you play a central role in facilitating communication and collaboration among various departments, such as Quality Assurance, Manufacturing, Regulatory Affairs, and R&D. You are often responsible for organizing cross-functional meetings, assigning action items, and ensuring that all stakeholders are aligned on timelines and objectives. This collaborative approach helps in identifying root causes effectively and implementing sustainable corrective and preventive actions. Building strong relationships and maintaining open communication channels are key to successfully managing CAPA projects and driving continuous improvement.

What are the key skills and qualifications needed to thrive as a CAPA Project Manager, and why are they important?

To thrive as a CAPA Project Manager, you need a deep understanding of quality management systems, root cause analysis, and regulatory compliance, often supported by a degree in life sciences or engineering. Familiarity with CAPA software platforms, document control systems, and industry standards such as ISO 13485 or FDA regulations is typically required. Strong analytical thinking, attention to detail, and excellent communication skills set top performers apart in this role. These skills and qualifications are crucial for ensuring effective corrective and preventive actions, maintaining compliance, and driving continuous improvement within an organization.

What is the difference between Capa Project Manager vs Capa Coordinator?

AspectCapa Project ManagerCapa Coordinator
CertificationsProject Management Professional (PMP), CAPA certifications often preferredCAPA-related certifications, some project management knowledge
Work EnvironmentOversees multiple projects, manages teams, strategic planningSupports CAPA activities, handles documentation, assists project managers
Employer & IndustryPharmaceutical, Medical Devices, ManufacturingSame industries, more focused on CAPA process execution

The Capa Project Manager typically leads CAPA projects, coordinating teams and ensuring strategic goals are met. The Capa Coordinator supports the CAPA process by managing documentation and assisting project managers. Both roles require CAPA knowledge, but the Project Manager has broader responsibilities and leadership duties.

What is a good career change for a Capa Project Manager?

A Capa Project Manager can transition into roles such as quality assurance manager, compliance officer, or process improvement specialist, leveraging skills in risk management, regulatory standards, and project coordination. Certifications like Six Sigma or PMP can facilitate such career shifts, and experience with root cause analysis is valuable in these fields.
Infographic showing various Capa Project Manager job openings in California as of September 2026, with employment types broken down into 100% Full Time. Highlights an 80% In-person, and 20% Hybrid job distribution.

Project Engineer III

Fremont, CA • On-site

System One
Business Consulting Services • 5 - 10K employees
Learn more about System Oneexternal

$90 - $100/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted 28 days ago

Job description

Job Title: Project Engineer III Location: Fremont, CA Type: Contract Compensation: $90-100/hr Contractor Work Model: Onsite Hours: 40.0 Overview A leading pharmaceutical company is seeking an experienced Project Engineer III to support engineering initiatives across Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems. The ideal candidate will bring strong technical expertise in GMP manufacturing environments, hands-on process equipment experience, and proven project leadership capabilities within biopharmaceutical operations. Responsibilities

  • Serve as the Engineering technical lead for Bulk Drug Substance (BDS), Drug Product (DP), and/or Process Science (PS) systems. This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.
  • Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
  • Might also own change control and participate in deviation/risk assessment activities.
  • Manage medium in size and complexity equipment related projects.
  • Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.
  • Uses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead.
  • Technical Analysis: including process system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.
  • Lead/participate in CAPEX/OPEX/CI projects.
  • Own risk assessment for new systems and changes to existing systems.
  • Write/review project execution plans.
  • Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...)
  • Technical approvers of protocols and periodic monitoring.
  • Lead/manage project team including overseeing & providing guidance on contractors activities.
  • Provides estimates of resource requirements.
  • Own technical optimization of the field of care.
  • Ensures that the facility equipment, machinery, documentation and technical support meet the compliance, quality and EHS standards.
  • Leads/motivates activities to ensure a continuous optimization process.
  • Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety).
  • Leads implementation and improvement of best practice of technical standards, procedures.
  • Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering.
  • Participates in peer-to-peer reviews as needed.
  • Collaborate with internal cross functional groups - Mfg, SCM, Quality, CMO, Finance, IT.
  • Work closely with external contingency worker, contractors, possible customers, auditor.
Requirements
  • Bachelor’s in Engineering, 5-10 years of related field experience or, Master’s in Engineering, +5 years’ of related field experience or P.E. License.
  • Minimum of 4 years’ working experience in a GMP manufacturing environment.
  • Minimum 5 years and hands on experience with process system/equipment.
  • Regulatory requirement per GMP, OSHA and FDA.
  • Knowledge of GMP compliance.
  • Technical expertise on process equipment/system.
  • Recognize safety requirements in manufacturing environment.
  • Equipment hands on experience.
  • Project leadership experience.
  • Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.
  • Expert on troubleshooting technical issues.
  • Owner of change control, deviation and CAPA.
  • Capable to lead projects (CAPEX or CI).
  • Capable of balance conflicting priorities and agile to manage changing priorities.
  • Ability to establish highly functional relationships with diverse personalities.
  • Physical demands/surroundings - work primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile.
  • Some domestic and international travel may be required.
  • Visual Demands - must be able to read and see clearly with or without correction lenses.
  • Excellent oral and written communication skills.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific

System One logo

About System One

Sourced by ZipRecruiter

System One helps employers get work done more efficiently and economically without compromising quality. Over our 35+ year history, we've helped connect thousands of talented people with innovative companies. The excitement of a perfect fit motivates us every single day.

Industry

Business consulting services and recruiting and staffing services

Company size

5,001 - 10,000 Employees

Headquarters location

Pittsburgh, PA, US

View All System One Jobs