Our client is a global biopharmaceutical company located near Neuchatel, Switzerland

Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and CVD.

The Role

This position is responsible for managing engineering projects regarding the implementation of equipment and process systems in GMP Facilities. He will ensure the development and review of engineering guidelines and standards for GMP utilities and OSD process technology.

Responsibilities:

Responsible for preliminary designs for manufacturing process equipment, including P&ID development and HAZOP facilitation.

Selection and review of suppliers.

Responsible for reviewing and approving design, PFD preparation, equipment and utilities sizing.

Provides technical guidance during project implementation, assures viability of the technology in proposed configuration, and adherence to company standards and practices.

Share best practices and promote harmonization while optimizing cost.

Establish engineering standards and keep content current and compliant through periodic review and successful integration with third-party designers/integrators.

Management of external engineering contractors and companies working on site.

Successfully interface with manufacturing team, maintenance team, project managers and engineering professionals.

Lead project execution, and equipment installation including commissioning, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).

Manages investment projects, and participates to the investment strategy and budget definitions.

Coordinates different teams as Project Manager working on new projects.

Leads or supports commissioning and qualification activities.

Participates in the selection of new contractors.

Support troubleshooting of existing pharmaceutical equipment.

Perform Technology Survey in his areas of expertise.

Promotes a company culture centred around Health & Safety to all employees and encourages them to maintain a safe and secure work environment at all times.

EHS:

Line Managers shall provide a safe and healthy work environment to their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.

Work closely with EHS to evaluate hazards and perform risk analysis.

Ensure that staff (including short-duration and temporary contracts) is properly informed on hazards and trained to act in consequence.

Promote safe practices and behaviors, and verify that EHS rules are implemented and respected.

Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future.

You

Our client is looking for someone who has:

3-5 years experience in a pharmaceutical company or other related industry.

Good knowledge of GMP and FDA regulatory requirements.

Good technical knowledge and experience in project management.

Good knowledge of process technologies (solid dosage forms, packaging…)

Good knowledge of technical infrastructures (HVAC, utilities...)

Good knowledge of the validation of procedures and systems.

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