What are the responsibilities and job description for the Process Engineer position at Compliance Workforce Solutions?
Job Type: Consulting
Overview: Compliance Workforce Solutions (CWS) is seeking a highly skilled and experienced Consultant Process Engineer to join our team near Waukegan, IL. The ideal candidate will have extensive experience in immunoglobulin (Ig) and fractionation processes within the pharmaceutical or biotechnology industry. This role will involve leading process validation efforts, ensuring compliance with regulatory standards, and driving continuous improvement initiatives.
Key Responsibilities:
- Lead and manage process validation activities for Ig and fractionation processes, including the preparation of protocols and reports.
- Ensure compliance with regulatory standards and guidelines, including FDA, EMA, and other relevant authorities.
- Conduct deviation investigations and manage Corrective and Preventive Actions (CAPA) to address process-related issues.
- Collaborate with cross-functional teams, including quality assurance, manufacturing, and engineering, to optimize process performance and efficiency.
- Develop and implement process improvement initiatives to enhance product quality and operational efficiency.
- Provide technical expertise and support for process-related projects and initiatives.
- Conduct hazard identification studies and manage change processes to ensure process safety and reliability.
Qualifications:
- Bachelor's degree in engineering, chemistry, biology, or a related life science discipline.
- Minimum of seven years of experience in process engineering within the pharmaceutical or biotechnology industry, with a focus on Ig and fractionation processes.
- Strong knowledge of process validation principles, methodologies, and industry standards.
- Experience in quality assurance, deviation investigations, and CAPA management.
- Excellent problem-solving skills and ability to work effectively in a team environment.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Knowledge of process safety principles and methodologies, and experience in hazard identification and change management.
Preferred Qualifications:
- Advanced degree in engineering, chemistry, biology, or a related field.
- Certification in process safety management or related areas.
- Experience with Lean Six Sigma or other process improvement methodologies.