Job Overview:
We are seeking a highly skilled and motivated Process Engineer to join our dynamic team As a Process Engineer, you will be responsible for designing, implementing, and optimizing manufacturing processes to ensure efficient production of high-quality pharmaceutical products. You will work closely with cross-functional teams to ensure compliance with industry standards, regulatory requirements, and company objectives.
Key Responsibilities:
Process Design & Optimization:
- Develop, implement, and optimize manufacturing processes for the production of pharmaceutical products.
- Conduct process simulations and troubleshoot issues to ensure smooth production flow.
- Identify and implement continuous improvement initiatives to enhance process efficiency, yield, and quality.
Process Validation & Qualification:
- Lead process validation and qualification efforts in accordance with regulatory guidelines and company standards.
- Create and execute protocols for process validation and ensure thorough documentation.
- Ensure that all processes comply with FDA, EMA, and other relevant regulatory requirements.
Troubleshooting & Technical Support:
- Provide technical support to manufacturing teams to resolve process-related issues.
- Monitor key process parameters and make adjustments as necessary to maintain optimal performance.
- Lead investigations into process deviations and implement corrective and preventive actions.
Collaboration & Cross-Functional Support:
- Work closely with R&D, Quality Assurance, and Manufacturing teams to develop new products and enhance existing ones.
- Provide engineering expertise and support during the technology transfer process from development to manufacturing.
- Collaborate with the validation and regulatory teams to ensure compliance with regulatory submissions and audits.
Documentation & Reporting:
- Prepare and maintain detailed documentation, including process flow diagrams, standard operating procedures (SOPs), and process control plans.
- Generate and analyze process data to provide insights into performance, improvement opportunities, and cost savings.
- Assist in preparing regulatory submissions and audits by providing necessary process documentation.
Qualifications:
Education & Experience:
- Bachelor's degree in chemical, Mechanical or Biomedical engineering, Pharmaceutical Sciences, or a related field.
- At least 2 years of experience in the pharmaceutical industry
Skills & Competencies:
- Strong problem-solving and analytical skills.
- Proficiency in process modeling software and statistical analysis tools.
- Excellent communication skills, both verbal and written.
- Ability to work effectively in a team-oriented, fast-paced environment.
- Detail-oriented with a strong focus on compliance and quality assurance
