What are the responsibilities and job description for the Validation and Quality Engineer position at Intellectt Inc?
Hello,
One of my clients is currently looking for a Validation and Quality Engineer - Pharmaceutical Industry, If you're interested or if your skills align with the role, please share your updated resume with me at sushma@intellectt.com.
Role: Validation and Quality Engineer - Pharmaceutical Industry
Duration: 12 Months
Location: Minnetonka, MN
Position Overview:
The Validation and Quality Engineer ensures that pharmaceutical manufacturing processes, equipment, and systems are in compliance with regulatory standards and meet quality expectations. This role focuses on validation activities, risk assessments, and ensuring consistent product quality throughout the production lifecycle.
Key Responsibilities:
- Validation Activities: Plan, execute, and document validation protocols (IQ, OQ, PQ) for equipment, systems, and processes to ensure compliance with GMP, FDA, and other regulatory requirements.
- Quality Assurance: Implement and maintain quality systems, including CAPA (Corrective and Preventive Actions) and non-conformance management.
- Regulatory Compliance: Support regulatory audits and inspections, ensuring all systems and processes meet industry standards (FDA, EMA, ICH).
- Documentation: Prepare and review validation documentation, including test plans, reports, and change control records.
- Continuous Improvement: Identify and address quality gaps, recommending improvements to manufacturing processes and equipment.
- Risk Management: Conduct risk assessments (e.g., FMEA) to ensure product quality and process reliability.
Key Skills:
- Strong knowledge of validation processes (IQ, OQ, PQ) and GMP.
- Expertise in regulatory compliance (FDA, EMA) and quality assurance systems (CAPA, non-conformance).
- Experience with risk management tools (FMEA, risk assessments).
- Proficient in documentation practices, including validation reports and SOPs.
- Familiarity with process control systems, automated systems, and manufacturing equipment.
- Excellent problem-solving, analytical, and project management skills.
- Strong communication skills for interacting with cross-functional teams and regulatory bodies.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 2 years in a validation or quality engineering role within the pharmaceutical or biotech industry.
- Six Sigma or Lean certifications (preferred).
- Experience with regulatory audits and quality control systems.
