What are the responsibilities and job description for the Product Engineer position at Aequor?
Job Title: Product Engineer I (Validation)
Location: Houston, TX
Duration: 24 Months Contract
Job Summary
We are seeking a Product Engineer I with experience in validation and quality engineering to support product and process validation activities throughout the product lifecycle. The ideal candidate will collaborate with cross-functional teams from design and development through testing, implementation, and post-launch support while ensuring compliance with quality and regulatory requirements.
Key Responsibilities
- Support and collaborate with project teams on validation activities from design, build, testing, and implementation phases.
- Execute and support validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Investigate and troubleshoot validation discrepancies related to systems, products, and processes.
- Create and maintain change control documentation.
- Perform root cause investigations for non-conforming events and support CAPA (Corrective and Preventive Action) activities.
- Evaluate CAPA effectiveness and ensure timely closure of quality actions.
- Ensure validation activities comply with applicable regulations, quality standards, and internal procedures.
- Collaborate effectively with cross-functional teams through open communication and teamwork.
- Apply statistical analysis techniques to assess process controls, manage risks, and support product quality decisions.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- 2 years of experience in Validation, Quality Engineering, Product Engineering, or Manufacturing Engineering.
- Hands-on experience with IQ/OQ/PQ validation activities.
- Experience with Change Control, CAPA, and Root Cause Analysis.
- Knowledge of quality systems and regulated environments such as GMP, FDA, or ISO standards.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
Preferred Qualifications
- Experience in Medical Device, Pharmaceutical, Biotechnology, or other regulated manufacturing industries.
- Familiarity with statistical analysis and risk management tools.
- Experience supporting product validation throughout the product lifecycle.