Single-use Project Manager
il y a 1 semaine
- Providing leadership with details design studies to enable strategic delivery of all Single use for the
- 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
- Good knowledge of Media buffer production equipment (single use mixer, single use tote, single use
- Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow
- 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
- 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
- Drive FAT/SAT activities in single-use expertise
- Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)
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
- 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.
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills.
We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at
FDA, Expertise, HAZOP Study, FMEA, Documentation, Communication, Pragmatism, Bioprocessing, Diagram, Solution Oriented, Delivery, Instrumentation, Process Equipment, Manufacturing, ASTM, Validation, Acting, Projects, Initiative taker, Regulation, Coordination, Training, Design, Planning, Piping systems, GLP, Sustainability, Commissioning, Material Balance, Engineering, Risk Analysis, Health & Safety, Leadership, cGMP, Process flow, Chromatography, Operations, Downstream, Media, Cost Estimating, Filtration, Project Management, URS, Assessment Design, HAZOP Study, CMC
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