Process Engineering Project Manager

Secteur
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Biotechnologies

Lieu
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Copenaghen

Niveau
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Confirmé

Contrat
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Permanent contract

Salaire
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€

• €

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.

• 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.

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