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Capa Engineer Jobs in Indiana (NOW HIRING)

Simtra BioPharma Solutions

CAPA Manager

Bloomington, IN · On-site

Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions. * Drive continuous improvement initiatives to strengthen ...

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

Quality Engineer City: Noblesville Country/Region: United States State: Indiana Business Area ... Participate in CAPA Review Board (CRB) meetings, as necessary. * Review calibrations out of ...

Integrated Resources INC

Manufacturing Engineer

Warsaw, IN · On-site

$70K - $90K/yr

Job title-Manufacturing Engineer Location - Warsaw IN Duration -8+ months (Possibility of extension ... Completes activities of the change control policy and Corrective and Preventive Action (CAPA ...

Boston Scientific

Quality Engineer III

Spencer, IN

$61K - $80K/yr

... CAPA records. • Determine the scope of product impact during PIR ET, PIR and field action scenarios. • Partner with manufacturing engineers and product supervisors to provide leadership within ...

Boston Scientific

Quality Engineer III

Spencer, IN

$61K - $80K/yr

Escalate CAPAs when appropriate and own and complete CAPA records. Determine the scope of product impact during PIR ET, PIR and field action scenarios. Partner with manufacturing engineers and ...

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

... CAPA records. • Determine the scope of product impact during PIR ET, PIR and field action scenarios. • Partner with manufacturing engineers and product supervisors to provide leadership within ...

Nexus Valve, Inc.

Quality Engineer

Fishers, IN · On-site

$64K - $83K/yr

The Quality Engineer is responsible for supporting the development, implementation, and continuous ... Familiarity with CAPA processes, root cause analysis, and 8D problem-solving methodologies.

Socket.dev

Quality Engineer

Fishers, IN · On-site

$70 - $100/hr

The Quality Engineer also supports supplier quality initiatives, internal audits, corrective ... Familiarity with CAPA processes, root cause analysis, and 8D problem-solving methodologies.

Aegis Worldwide

Quality Engineer

Dunkirk, IN · On-site

$64K - $83K/yr

Perform root cause analysis and implement corrective and preventive actions (CAPA) to address ... Collaborate with engineering, manufacturing, suppliers, and cross-functional teams to resolve ...

New

H. T. PROF Group

Manufacturing Engineer

Indianapolis, IN · On-site

$90 - $120/hr

The Manufacturing Engineer is responsible for developing, implementing, validating, and optimizing ... APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis. * Process validation ...

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All JobsCapa Engineer JobsCapa Engineer Jobs in Indiana

Capa Engineer information

See Indiana salary details

$37.1K

$96.8K

$130.8K

How much do capa engineer jobs pay per year?

As of Aug 23, 2026, the average yearly pay for capa engineer in Indiana is $96,824.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,900.00 and $110,900.00 per year, depending on experience, location, and employer.

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 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 are popular job titles related to Capa Engineer jobs in Indiana?

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

What job categories do people searching Capa Engineer jobs in Indiana look for?

The top searched job categories for Capa Engineer jobs in Indiana are:

Capa Engineer jobs near you
Infographic showing various Capa Engineer job openings in Indiana as of August 2026, with employment types broken down into 90% Full Time, 6% Part Time, and 4% Contract. Highlights an 86% Physical, 5% Hybrid, and 9% Remote job distribution, with an average salary of $96,824 per year, or $46.5 per hour.

CAPA Manager

Simtra BioPharma Solutions

Bloomington, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 6 days ago

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra?Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
This role:
The CAPA Manager is responsible for leading and managing the Corrective and Preventive Action (CAPA) Quality System to ensure compliance with corporate, client, and regulatory requirements. This role oversees investigations, root cause analysis, and implementation of effective corrective and preventive actions across the organization. The CAPA Manager collaborates with cross-functional teams and serves as a key point of contact for CAPA-related activities. This position reports to the Sr. Manager, Quality.
The responsibilities:
  • Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines.
  • Oversee day-to-day operation of the CAPA Quality System, including recurring CAPA meetings and timely closure of CAPAs.
  • Lead and facilitate investigations for deviations.
  • Utilize structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify root causes and implement effective corrective/preventive actions.
  • Review and approve CAPA documentation for completeness and accuracy.
  • Escalate quality issues to Sr. Manager, Quality or Quality Director as necessary.
  • Train and qualify deviation authors, CAPA and Continuous Improvement (CI) owners and approvers to ensure competency in investigation and documentation processes.
  • Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.
  • Prepare and present CAPA metrics and trend reports for management review and regulatory inspections.
  • Provide training and guidance to personnel on CAPA processes and best practices.
  • Support internal, client, and regulatory audits related to CAPA activities.
  • Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions.
  • Drive continuous improvement initiatives to strengthen the CAPA system and overall quality performance.

The qualifications:
  • Bachelor's degree required, preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master's degree with 3 years of pharmaceutical or medical device industry experience
  • Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
  • Proven experience managing CAPA systems and leading investigations.
  • Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools.
  • Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

Physical / safety requirements:
  • Duties may require overtime work, including nights and weekends.
  • Position may require sitting or standing for long periods of time.

In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

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