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Contract Capa Engineer Jobs in Ohio (NOW HIRING)

Integration Systems

Quality Engineer

Dayton, OH · On-site

$70K - $90.40K/yr

... actions (CAPA), and drive continuous improvement initiatives. • Interface with DoD customers ... S. citizenship required due to government contract requirements. Preferred Qualifications: • ...

ACL Digital

Engineer Senior

New Albany, OH · On-site

$100.40K - $137.90K/yr

... contract to start Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment ... Deviation/CAPA/EV Owner. Change Control Owner. * Relationships: Build networks with commercial and ...

Actalent

Entry Level Engineer

Union City, OH · On-site

$65.60K - $84.70K/yr

Contribute to the development and execution of corrective and preventive actions (CAPA) to address ... Job Type & Location This is a Contract to Hire position based out of Dayton, OH. Pay and Benefits ...

New

GE Aerospace

OEM Quality Engineer

Beavercreek, OH · On-site

$67.10K - $86.60K/yr

Implement/verify CAPA to prevent recurrence * Process and product assurance: Support manufacturing ... This document does not create a contract of employment with any individual. This role requires ...

General Electric Company

OEM Quality Engineer

Beavercreek, OH · On-site

$66.80K - $86.30K/yr

Implement/verify CAPA to prevent recurrence * Process and product assurance: Support manufacturing ... This document does not create a contract of employment with any individual. This role requires ...

General Electric Company

Lead Quality Engineer

Evendale, OH · On-site

$66.10K - $85.40K/yr

Digital quality system experience (NCR/MRB/CAPA) and data analysis. * ASQ CQE and/or Lean/Six Sigma ... This document does not create a contract of employment with any individual. This role requires ...

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Contract Capa Engineer information

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

To excel as a Contract CAPA Engineer, you need a strong background in quality engineering, root cause analysis, and regulatory compliance, often supported by a degree in engineering or a related field. Expertise in CAPA management systems, quality management software (like TrackWise), and knowledge of ISO 13485 or FDA regulations are typically required. Strong analytical thinking, attention to detail, and effective communication skills help drive successful corrective and preventive actions. These competencies ensure regulatory compliance, minimize risks, and maintain product quality in regulated industries.

What are some common challenges faced by a Contract CAPA Engineer when implementing corrective and preventive actions across multiple client sites?

As a Contract CAPA Engineer, one of the main challenges is adapting to different organizational processes and quality management systems at each client site. Each company may have unique documentation standards, regulatory requirements, and communication protocols, which can complicate the investigation and resolution of quality issues. Balancing multiple projects, aligning stakeholders, and ensuring timely closure of CAPA actions while strictly adhering to compliance standards requires strong organizational and interpersonal skills. Successful engineers proactively build rapport with client teams and remain detail-oriented to ensure all corrective and preventive actions are both effective and audit-ready.

What is a Contract CAPA Engineer?

A Contract CAPA Engineer is a professional hired on a temporary or project basis to manage and oversee Corrective and Preventive Action (CAPA) processes within an organization, typically in regulated industries such as pharmaceuticals, medical devices, or manufacturing. Their primary responsibility is to investigate issues, identify root causes, and implement solutions to prevent recurrence of non-conformities. They ensure that CAPA processes meet regulatory standards and help maintain compliance with industry guidelines. Contract CAPA Engineers often work with cross-functional teams to drive continuous improvement and ensure product quality.

What is the difference between Contract Capa Engineer vs Contract Failure Analysis Engineer?

AspectContract Capa EngineerContract Failure Analysis Engineer
Required CredentialsBachelor's in Engineering, Six Sigma, Root Cause AnalysisBachelor's in Engineering, Six Sigma, Root Cause Analysis
Work EnvironmentManufacturing, Aerospace, AutomotiveManufacturing, Aerospace, Automotive
Employer & Industry UsageQuality departments, Reliability teamsQuality departments, Reliability teams
Common Search & ComparisonYesYes

Both roles focus on quality and reliability, requiring similar certifications and working in manufacturing or aerospace industries. The Contract Capa Engineer primarily manages corrective and preventive actions to address issues, while the Contract Failure Analysis Engineer investigates root causes of failures. They often collaborate but serve distinct functions within quality assurance teams.

What are popular job titles related to Contract Capa Engineer jobs in Ohio? For Contract Capa Engineer jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Contract Capa Engineer jobs in Ohio look for? The top searched job categories for Contract Capa Engineer jobs in Ohio are:
What cities in Ohio are hiring for Contract Capa Engineer jobs? Cities in Ohio with the most Contract Capa Engineer job openings:
Contract Capa Engineer jobs near you
Infographic showing various Contract Capa Engineer job openings in Ohio as of May 2026, with employment types broken down into 1% Locum Tenens, 1% Internship, 3% Full Time, 86% Part Time, 1% Temporary, and 8% Contract. Highlights an 82% Physical, and 18% Remote job distribution.
Validation Engineer, CSV Biopharma (JP12934-R)

Validation Engineer, CSV Biopharma (JP12934-R)

3 Key Consulting

New Albany, OH

$35 - $40/hr

Other

Posted 15 days ago

Job description

Job Title:Validation Engineer, CSV Biopharma (JP12934-R)
Location: New Albany, OH. 43054
Business Unit: Ops Digital Technology Innovation
Employment Type: Contract
Duration: 6+ months with likely extension
Rate: $35-40/Hr with benefits
Posting Date:3/18/2025
Notes: Onsite New Albany, OH - must be local. Standard hours.
3 Key Consulting is hiring! We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client's Ohio computer systems validation.
Top Must Have Skill Sets:
  • Experience with testing tools (ALM, or Kneat or ValGenesis).
  • Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management.
  • Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
  • Understanding of industry standards and best practices for computer system validation such as GAMP 5.
  • Must have experience with deviations
  • IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery)

Day to Day Responsibilities:
  • Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
  • Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
  • Provide support on completion of validation deliverables as required per the project.
  • Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
  • Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
  • Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
  • Support regulatory inspections and internal audits as required.

Basic Qualifications:
  • Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
  • 2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).
  • Experience with ALM or Kneat testing tool is plus.
  • 2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management.
  • 3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
  • 4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.

Why is the Position Open?
Supplement additional workload on team.
Red Flags:
  • cannot support onsite operations
  • Overly long or irrelevant resume
  • Exaggerated or vague job titles and responsibilities
  • Lack of achievements or quantifiable results

Interview Process:
WebEx or onsite.
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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