Biological/Pharmaceutical Process Engineer

Job Overview: We are seeking an experienced and highly skilled Intermediate Level Biological/Pharmaceutical Process Engineer to join our dynamic team. As an integral member of our organization, you will be responsible for designing, implementing, and optimizing pharmaceutical manufacturing processes to ensure efficient production, compliance with regulatory standards, and the highest level of product quality. This role requires strong technical expertise, problem-solving abilities, and a deep understanding of pharmaceutical manufacturing principles.

Responsibilities:

1.Process Design and Development:

·Design and develop pharmaceutical manufacturing processes, including equipment selection, process flow, and operational parameters.

·Ensure compliance with regulatory guidelines, industry standards, and Good Manufacturing Practices (GMP) throughout process design and development.

2.Process Optimization:

·Continuously evaluate and improve existing manufacturing processes to enhance efficiency, yield, and product quality.

·Conduct process troubleshooting and root cause analysis for deviations, non-conformances, and quality issues.

·Identify and implement process improvements, such as equipment modifications, automation, or procedural changes, to optimize production and reduce costs.

3.Scale-Up and Technology Transfer:

·Collaborate with Engineering teams to facilitate the successful scale-up and technology transfer of new products to commercial manufacturing.

·Ensure seamless integration of processes, equipment, and materials during scale-up, while maintaining product quality and consistency.

·Conduct risk assessments and develop strategies to mitigate potential challenges during scale-up and technology transfer processes.

4.Validation and Qualification:

·Lead the validation and qualification activities for manufacturing processes, equipment, and facilities, in accordance with regulatory requirements and company guidelines.

·Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

·Collaborate with Quality Assurance teams to review and approve validation documentation and ensure compliance with regulatory standards.

5.Process Monitoring and Control:

·Establish robust process monitoring systems to ensure real-time data collection, analysis, and control of critical process parameters.

·Implement statistical process control techniques to monitor process performance and identify opportunities for improvement or intervention.

·Develop and maintain standard operating procedures (SOPs) for process monitoring and control activities.

6.Continuous Improvement and Innovation:

·Stay abreast of advancements in pharmaceutical manufacturing technologies, industry trends, and regulatory requirements.

·Proactively identify opportunities for process optimization, innovation, and cost reduction initiatives.

·Collaborate with cross-functional teams to implement best practices and drive continuous improvement in manufacturing processes.

Qualifications:

1.Bachelor's or Master’s degree in Chemical or Biotechnology Engineering, or a related field.

2.Minimum of 3 years of experience in pharmaceutical process engineering, preferably in a GMP-regulated environment.

3.Strong knowledge of pharmaceutical manufacturing processes, including aseptic filling of liquids, and sterile products.

4.In-depth understanding of regulatory guidelines

5.Experience with process validation, including IQ, OQ, and PQ activities.

6.Excellent analytical and problem-solving skills, with a keen attention to detail.

7.Strong interpersonal and communication skills to collaborate effectively with cross-functional teams.

8.Ability to prioritize and manage multiple projects simultaneously, while meeting deadlines.

9.Self-motivated and proactive, with a passion for continuous learning and professional development.