Quality Process Engineer
Quality Process Engineer
Posted on :
09-08-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
09-08-2025
Job Description
Job Description:
- The Quality Process Engineer will be responsible for developing and maintaining process control systems to ensure consistent product quality with a focus on supporting the insourcing of materials and components.
- This role leads cross-functional efforts to qualify internal processes validate materials and transition manufacturing activities from external suppliers.
- The engineer ensures compliance with GMP GDP and regulatory standards while driving process improvements supporting investigations and managing documentation throughout the insourcing lifecycle.
- Supporting Insourcing of different vendor chemicals or suppliers. HEAVY on the insourcing aspects.
- Develop implement and maintain process control systems to ensure consistent product quality and process efficiency especially in areas impacted by insourced materials.
- Analyze production and supply chain processes to identify bottlenecks deviations and improvement opportunities related to the insourcing of components or materials.
- Collaborate with Quality Assurance Product Development Process Development and Manufacturing teams to support the insourcing of materials by qualifying internal processes materials and suppliers.
- Lead and support cross-functional initiatives to transition manufacturing processes or materials from external suppliers to internal operations.
- Facilitate root cause analysis during quality investigations particularly when introducing new internal processes or materials and incorporate corrective and preventive actions.
- Develop and review technical documentation (e.g. batch records material specifications validation protocols) to support the qualification and validation of insourced materials.
- Coordinate with engineering and project teams to define inspection criteria material acceptance standards and validation procedures for internally sourced materials.
- Manage documentation routing review cycles and project tracking to ensure timely completion of insourcing projects.
- Prepare and route documentation for approval ensuring adherence to Good Documentation Practices (GDP) and applicable regulatory requirements (e.g. FDA GMP).
- Act as a liaison across internal teams (Manufacturing Supply Chain IT Quality Control etc.) to ensure seamless integration of insourced materials.
- Occasionally interface with external suppliers and partners during the transition period to gather technical data or resolve quality issues.
- Support execution of project plans related to material insourcing ensuring actions milestones and deadlines are met.
- Provide training for team members on new processes or materials introduced through insourcing efforts.
- Ensure compliance with internal SOPs GMP standards GDP and regulatory requirements during all phases of material insourcing and process control.
- Culture and Expectations.
- Dress Code: Business Casual.
- Work Environment: Combination of office work lab work and manufacturing floor work.
- Safety Equipment Provided by client: Safety glasses lab coats steel toe shoes safety vests (used as needed).
- Bachelors degree in engineering Chemistry Life Sciences or related technical field.
- 3 years of experience in quality process engineering or manufacturing environment preferably in a regulated industry.
- Strong understanding of GMP GDP and FDA quality system regulations.
- Demonstrated ability to lead cross-functional projects and manage multiple priorities.
- Excellent written and verbal communication skills.
- Proficiency in technical writing and documentation control systems.
- Degrees and/or Certifications:
- Experience with validation process transfer or insourcing/technology transfer is highly preferred.
Employment Type
Full-time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
