Single-use Project Manager

Contracting – Braine l’Alleud

• Providing leadership with details design studies to enable strategic delivery of all Single use for the

project execution phase until the handover to the operations.

• Developing planning & cost estimates for all single use.

• Partnering with engineering firms to ensure proper support in delivering the single use.

• Defining the technical resources requirements

• Consolidating and reviewing the specifications (e.g. URS, Technical Specifications)

• Ensuring strong communication with stakeholders, with his/her workstream and project team

• Strong background within manufacturing DSP (downstream) process equipment (Single use UF/MF

filtration skids, Single use Chromatography skids, Single use TTF/VRF, Single use mixer)

• Good knowledge of Media buffer production equipment (single use mixer, single use tote, single use

aseptic connections, single use bags)

• Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow

Diagrams) is required, as well as mass balances.

• Ability to act as technical process expert in single use during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA

• Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant

• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is

preferred.

• Experience in large and complex projects as well as both formal and informal leadership / coordination

• Integrate safety, sustainability, and green assessment in the design

• Follow-up and challenges of the engineering office

• Define List of Deliverables for his discipline

• Provide project deliverables of his discipline to Engineering Leader

• Write the specifications related to Single-Use expertise.

• Assist to write commissioning documentation and ensure that the supplier's documentation is

acceptable to perform verification (ASTM 2500)

• Drive FAT/SAT activities in single-use expertise

• Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)

Organize the training of the final user in its area of expertise & provide technical documentation in

to finalize the Hand-over

• Actively perform the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the

associated punch list

• Respect documentation strategy

• Ensure compliance to HSE requirements and rules

• Minimum 15 years of experience within pharmaceutical companies and working with Engineering offices.

• Strong Downstream Bioprocess Single-use technical expertise

• Good Knowledge of cGxP requirements

• Manage a fluent communication between different stakeholders (Engineering office, User and others)

• Good teamwork

• Rigorous, Accountable, Involved, Proactive

• Pragmatism to solve issues, solution oriented.

• Fully acting at own's initiative.