Job Description
Job Summary
We are seeking an Engineering Project Manager with a focus on process optimization and management expertise to join our team. In this role, you will lead cross-functional teams, drive process excellence, and ensure the successful execution of projects related to the production of multiple types of pharmaceutical products.
Responsibilities
- Lead and manage cross-functional teams in designing, developing, and optimizing manufacturing processes in the life sciences sector.
- Oversee process simulations, evaluate and implement process improvements, and resolve complex operational issues.
- Develop and review comprehensive process documentation, including P&IDs, standard operating procedures, and batch records.
- Ensure full compliance with industry-specific regulations, quality standards, and regulatory requirements.
- Provide technical expertise in areas such as aseptic processing, downstream and upstream processing, filtration, sterilization, and purification techniques.
- Lead or participate in process validation activities to ensure product quality and regulatory compliance.
- Investigate and address deviations, incidents, and quality issues, and recommend corrective and preventive actions.
- Coordinate process scale-up and technology transfer activities from development to commercial production.
- Lead equipment selection, qualification, and maintenance efforts.
- Stay informed about industry trends and emerging technologies to enhance processes and methodologies continually.
Required Profile
- Bachelor's or Master's degree in Chemical Engineering, Bioprocess Engineering, or a related field.
- Minimum of 5-10 years of process engineering experience in the life sciences industry (pharmaceuticals, food and beverage, cosmetics, etc.).
- Previous experience in managing projects and Project Manager or Project Engineer is needed
- Excellent knowledge of industry-specific regulations and quality standards.
- Proficiency in process modeling and simulation tools.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Ability to work effectively within cross-functional teams and independently.
- Experience with process validation, technology transfer, and equipment qualification is a plus.
DK
