Quality Engineer - Validation Focus
Quality Engineer - Validation Focus
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Job Description
Quality Engineer
St. Paul MN Direct Hire Hybrid $75k 90k
Konik is partnering with a local pharmaceutical manufacturer seeking an experiencedQuality Engineerto support process development design transfer and commercial production of pharmaceutical and medical device products.This role ensures compliance with regulatory requirements and customer specifications with a focus on pharmaceutical film products. Key processes include mixing coating slitting converting and packaging.
Quality Engineer Responsibilities:
- Process & Product Development: Support product development from feasibility to validation ensuring robust processes using Quality by Design (QbD) principles and Design of Experiment (DoE) methodologies.
- Risk Management: Conduct risk assessments including Failure Mode and Effects Analysis (FMEA) Annual Product Reviews and process verification to identify and mitigate potential failures.
- Regulatory Compliance: Develop and maintain documentation such as batch records protocols reports and SOPs in compliance with cGMP ISO and industry standards.
- Change Control & Deviations: Lead root cause investigations implement corrective actions and assess the impact of changes on quality and compliance.
- CrossFunctional Collaboration: Work closely with R&D manufacturing and regulatory teams to improve internal processes and ensure seamless design transfer to production.
- Equipment & Facilities Support: Assist in qualification and validation of equipment systems and software ensuring alignment with industry best practices.
Quality Engineer Qualifications:
- Bachelors degree in engineering life sciences or related field.
- 5 years of experience in a quality role within pharmaceutical biopharmaceutical or medical device industries.
- Strong knowledge of manufacturing processes cGMP ISO and regulatory guidelines.
- Experience with risk management quality systems and process validation.
- We are unable to sponsor work visas. Candidates must be legally authorized to work in the U.S. at the time of application and in the future without employer sponsorship.
Benefits:
- Health Dental and Vision insurance
- Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
- Vacation & Sick Time
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Konik is an equalopportunity employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin sex sexual orientation gender identity age status as a protected veteran status as a qualified individual with a disability or any other protected class status.
Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.
Employment Type
Full Time
