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Senior Quality Process Engineer Jobs in Indiana (NOW HIRING)

INCOG BioPharma Services

Senior Process Engineer

Fishers, IN · On-site

$97.30K - $125.90K/yr

Description The Senior Process Engineer will provide technical assessments, rationales and approval ... by ensuring quality outcomes and accelerating their route to market, we want to hear from you.

Saab

Senior Quality Engineer

New Ross, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Otterbein, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Flora, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Kokomo, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Kokomo, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Mellott, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Attica, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Chalmers, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Hillsboro, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Burlington, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Boswell, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Fair Oaks, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Lafayette, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Goldsmith, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

New Richmond, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

Saab

Senior Quality Engineer

Romney, IN · On-site

$92.20K - $115.30K/yr

... seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal ... Support process development by integrating quality policy into procedures and continual process ...

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Senior Quality Process Engineer information

What are the key skills and qualifications needed to thrive as a Senior Quality Process Engineer, and why are they important?

To excel as a Senior Quality Process Engineer, you need a solid background in engineering principles, quality management systems, and process improvement methodologies, often supported by a bachelor's degree in engineering or a related field. Familiarity with Six Sigma, Lean tools, ISO standards, statistical analysis software, and quality auditing certifications like CQE are typically required. Strong analytical thinking, leadership, and effective communication skills set candidates apart when driving cross-functional initiatives. These competencies are crucial for ensuring product quality, regulatory compliance, and ongoing operational efficiency in manufacturing environments.

How does a Senior Quality Process Engineer typically collaborate with cross-functional teams to drive process improvements?

A Senior Quality Process Engineer frequently works alongside manufacturing, design, and supply chain teams to identify inefficiencies and implement quality enhancements. This collaboration often involves leading root cause analysis sessions, facilitating process mapping workshops, and ensuring that corrective actions are communicated and adopted across departments. Effective communication and project management skills are essential, as the engineer acts as a bridge between technical and non-technical stakeholders to align quality objectives with business goals.

What does a Senior Quality Process Engineer do?

A Senior Quality Process Engineer is responsible for designing, implementing, and improving processes to ensure products meet established quality standards. They analyze production systems, identify areas for improvement, and develop strategies to enhance efficiency and reduce defects. This role often involves collaborating with cross-functional teams, conducting root cause analyses, and ensuring compliance with industry regulations. Senior Quality Process Engineers also mentor junior staff and help drive continuous improvement initiatives within the organization.

What is the difference between Senior Quality Process Engineer vs Quality Assurance Engineer?

AspectSenior Quality Process EngineerQuality Assurance Engineer
CredentialsBachelor's or Master's in Engineering, certifications like CQEBachelor's in Engineering, certifications like CQE or ASQ certifications
Work EnvironmentManufacturing, industrial, or production settingsProduct development, software, or manufacturing environments
ResponsibilitiesDesigning quality processes, process improvements, complianceTesting, inspection, ensuring product quality, audits

The main difference is that Senior Quality Process Engineers focus on developing and optimizing quality processes and ensuring compliance, often working on process improvements. Quality Assurance Engineers primarily focus on testing and inspecting products to ensure they meet quality standards. Both roles require similar certifications and often work in manufacturing or industrial settings, but their core responsibilities differ in scope and focus.

What are popular job titles related to Senior Quality Process Engineer jobs in Indiana? For Senior Quality Process Engineer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Senior Quality Process Engineer jobs in Indiana look for? The top searched job categories for Senior Quality Process Engineer jobs in Indiana are:
What cities in Indiana are hiring for Senior Quality Process Engineer jobs? Cities in Indiana with the most Senior Quality Process Engineer job openings:
Senior Quality Process Engineer jobs near you
Senior Process Engineer

Senior Process Engineer

INCOG BioPharma Services

Fishers, IN • On-site

$97.30K - $125.90K/yr

Full-time

Posted yesterday

Job description

Description
The Senior Process Engineer will provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors.
Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.
Essential Job Functions:
• Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Mentor and train other team members.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
• Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
• Participate and report to a cross-functional team to advance production activities.
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
• Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)
• Execute engineering studies, recipe development, and validation test cases.
• Work with vendors and suppliers to define requirements and understand functional specifications.
• Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.
• Work flexible hours for the coverage of the production facility.
Special Job Requirements:
• Sterile Injectables (Formulation, aseptic filling, inspection, and/or packaging)
• Knowledge of data management tools and RCM.
• Bachelor's degree or higher in engineering, bioengineering, or related scientific field.
• 10+ years' experience in biopharmaceutical or other GXP regulated industry.
Additional Preferences:
  • CMO/CDMO experience
    • Technical and/or lean six sigma certifications
    • Electro-mechanical practical experience

Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.

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