ZipRecruiter

Log In

1

Capa Engineer Jobs in Exton, PA (NOW HIRING)

Hologic Inc.

Manager, Engineering

Newark, DE · On-site

$122K - $200K/yr

Lead root cause analysis and corrective/preventive actions (CAPA) for process-related issues ... Bachelor's degree in Engineering required * MS in Engineering or MBA preferred * 7+ years ...

Hologic

Manager, Engineering

Newark, DE · On-site

$122K - $200K/yr

Lead root cause analysis and corrective/preventive actions (CAPA) for process-related issues ... Bachelor's degree in Engineering required * MS in Engineering or MBA preferred * 7+ years ...

MSD

AVP, Engineering

West Point, PA

$174K - $224K/yr

... Engineering to drive strategic priorities, strengthen network performance, and deliver business ... excellence, CAPA effectiveness, and continuous improvement. * Champion digital, analytics, and ...

New

previous page

Showing results 41-60

All JobsCapa Engineer JobsCapa Engineer Jobs in Exton, PA

Capa Engineer information

See Exton, PA salary details

$37.6K

$98.2K

$132.7K

How much do capa engineer jobs pay per year?

As of Aug 14, 2026, the average yearly pay for capa engineer in Exton, PA is $98,206.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,100.00 and $112,400.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the CAPA engineer position, and why are they important?

To thrive as a CAPA Engineer, you need a solid background in quality engineering, root cause analysis, and process improvement, typically supported by a degree in engineering or a related technical field. Familiarity with CAPA management systems, quality standards such as ISO 13485 or ISO 9001, and tools like Six Sigma or FMEA is highly valuable. Strong problem-solving abilities, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure effective identification, documentation, and resolution of quality issues, helping organizations maintain regulatory compliance and deliver high-quality products.

What is a CAPA engineer?

A CAPA (Corrective and Preventive Action) Engineer is responsible for identifying, investigating, and resolving quality issues in manufacturing or engineering processes. They analyze root causes of defects, implement corrective measures, and develop preventive strategies to ensure compliance with industry regulations. CAPA Engineers work closely with cross-functional teams to improve product quality, streamline processes, and maintain regulatory compliance. They also document findings, track action plans, and support continuous improvement initiatives to reduce future risks.

What are the main daily responsibilities of a CAPA engineer?

A CAPA Engineer's daily responsibilities typically include investigating potential or actual nonconformities, conducting root cause analyses, and developing corrective and preventive action plans to resolve and prevent future issues. They also collaborate closely with cross-functional teams such as manufacturing, quality assurance, and regulatory affairs to ensure solutions are practical and compliant with industry standards. Additionally, CAPA Engineers monitor the progress and effectiveness of implemented actions, prepare documentation for audits, and participate in continuous process improvement initiatives. This role is crucial for maintaining the highest quality standards and ensuring compliance in regulated industries such as medical devices or pharmaceuticals.

What are popular job titles related to Capa Engineer jobs in Exton, PA?

For Capa Engineer jobs in Exton, PA, the most frequently searched job titles are:

Capa Engineer jobs near you
Infographic showing various Capa Engineer job openings in Exton, PA as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, and 6% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $98,206 per year, or $47.2 per hour.

COMPUTER SYSTEM VALIDATION LEAD in Wilmington, DE

Northern Base

Wilmington, DE • On-site

Full-time

Re-posted 8 days ago

Job description

COMPUTER SYSTEM VALIDATION LEAD
Wilmington, DE
Fulltime
10+ years of experience
​
Must Have Technical/Functional Skill
•  8–10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
• Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
• Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).
• Familiarity with GAMP 5 and risk-based validation approach.
• Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
• Working knowledge of change control, deviation management, CAPA, and periodic review.
• Good documentation practices; strong stakeholder management and communication skills.
 
Roles & Responsibilities
•  Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
• Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
• Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
• Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
• Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
• Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
• Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
• Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
• Mentor junior CSV team members; contribute to process improvements, templates, and best practices.