Position Overview: We are seeking a motivated and experienced Process Engineer with a background in life sciences or pharmaceuticals to contribute to our diverse portfolio of projects. The successful candidate will play a key role in designing, optimizing, and validating manufacturing processes to ensure the production of high-quality pharmaceutical products that meet regulatory requirements and industry standards.
Responsibilities:
- Collaborate with cross-functional teams including scientists, engineers, and regulatory experts to develop and implement robust manufacturing processes for pharmaceutical products.
- Conduct feasibility studies, process simulations, and risk assessments to evaluate process alternatives and identify optimal solutions.
- Design and optimize unit operations including mixing, filtration, purification, and sterilization processes.
- Develop and execute process validation protocols in accordance with regulatory guidelines (e.g., FDA, EMA) and industry best practices.
- Troubleshoot process issues and implement corrective and preventive actions to ensure product quality and compliance.
- Provide technical expertise and guidance to support technology transfer and scale-up activities from development to commercial manufacturing.
- Collaborate with vendors and external partners to evaluate new technologies and equipment for process improvements.
- Prepare technical documentation, including process descriptions, batch records, and standard operating procedures (SOPs).
- Stay abreast of industry trends, emerging technologies, and regulatory changes related to pharmaceutical process engineering.
Qualifications:
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or related field. Master's degree preferred.
- Minimum of 5 years of experience in process engineering within the life sciences or pharmaceutical industry.
- Solid understanding of cGMP regulations, FDA guidelines, and industry standards relevant to pharmaceutical manufacturing.
- Experience with process validation, including IQ/OQ/PQ protocols and execution.
- Proficiency in process simulation software (e.g., SuperPro Designer, BioSolve) and statistical analysis tools.
- Strong analytical and problem-solving skills with the ability to optimize processes and troubleshoot technical issues.
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
- Proven ability to manage multiple projects simultaneously and meet project deadlines.
- Experience with technology transfer and scale-up activities is a plus.
Benefits:
- Competitive salary and comprehensive benefits package.
- Opportunities for professional development and career advancement.
- Exciting and challenging projects at the forefront of pharmaceutical innovation.
- Collaborative and supportive work environment with a focus on teamwork and employee well-being.
