Associate Director – Quality Engineer
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Upload Your ResumeAbout This Role
The Associate Director, Quality Engineer provides technical guidance and leadership to FUME Operations and Facilities Management, ensuring adherence to quality standards for site operations. This role focuses on facility, utility, maintenance, and equipment (FUME) systems within oligonucleotide and small molecule processes.
Responsibilities
- Provide direct quality oversight of production, engineering, automation, and laboratory operations.
- Review and approve documents including procedures, change control proposals, deviations, and equipment/system qualification/validation.
- Provide quality guidance and recommendations regarding manufacturing, materials, utilities, maintenance, and laboratory issues.
- Participate in aberrant data investigations.
- Conduct analytical data review, including stability data.
- Disposition API Intermediates and raw materials.
- Provide coaching, feedback, and mentoring to engineering and QA regarding quality systems execution.
- Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.
- Contribute to and review Annual Product Reviews, Quarterly Product and Process Self-Assessments, and equipment/computer system periodic reviews.
- Conduct gap assessments of global requirements and ensure implementation of governing standards.
- Participate in and/or lead/support self-inspection activities and regulatory inspections.
- Assist business partners in the interpretation of regulatory and corporate requirements.
Requirements
- BS in Engineering or a science-related field or equivalent experience
- Minimum of 8 years of relevant experience
Qualifications
- BS in Engineering or a science-related field or equivalent experience
- Minimum of 8 years of relevant experience.
Nice to Have
- Experience in API manufacturing, QA or Engineering
- Hands-on experience with oligonucleotide and small molecule processes
- Experience with system and equipment qualifications
- Demonstrated strong written and verbal communications skills
- Strong attention to detail
- Proficiency with computer system applications
- Knowledge of cGMPs and quality systems
- Understanding of statistical tools and analysis
- Excellent interpersonal and networking skills
- Ability to organize and prioritize multiple tasks
- Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs
Skills
* Required skills
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...