Process Workstream Lead
Brabant Wallon – contracting
Our partner is looking for a Process Workstream Lead to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
TECHNICAL SKILLS
- Lead the engineering process team and act as the spoc for all process equipment from design until the handover after verification. Organize his/her team to address to address the best engineering good practice and collaborate with key users.
- He/She is in the driver seat, with a full management of supplier, User, QA, EHS, C&V team and will be measure with the success of process equipment implementation.
- Strong background within manufacturing USP & DSP (upstream & downstream) bioprocess equipment (Single use systems: bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer), Fill and finish, autoclave and washer.
- Expert of single use equipment and aseptic used
- Strong knowledge on GEP and global engineering standards.
- Ability to Lead P&ID and PFD setup is required, as well as mass balances, FS, HSD, SDS,…
- Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
- Knowledge and expertise in verification ASTM E2500
- 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
- Capable to benchmark with peers in the industry and able to identify latest trends
- Excellent communication skills in order to present frequent reports to Management.
BASIC & DETAILED DESIGN
- Define the applicable standards/norms/engineering guidelines for the project
- Provide Engineering offices with the applicable standards
- Challenge technical solutions coming from Engineering office
- Integrate safety, sustainability and green assessment in the design
- Define List of Delivrables for his discipline
- Provide project delivrables of his discipline to Engineering Leader
- Follow-up on progress/ ETC.
CONSTRUCTION
- Based on progress report of the construction manager, perform on a regular basis field spot check follow-up
- Organize quality checks on field before each technical milestone activiy.
- Communicate the day to day schedule (planning level 4) to the Engineering Leader and construction manager
- Ensure a good communication with other Specialists linked to its activity (Battery limits)
- Maintain his knowledge accuracy based on new technology. Keep up-to-date
Documentation
- Define battery limit and RACI matrix with Engineering Leader
- Update drawings in its area of expertise
- Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500)
- Perform FAT/SAT activities in its area of 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 perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
- Respect documentation strategy
HSE
- Ensure compliance to HSE requirements and rules
- Ensure the 3 green lights are scheduled and correctly organized/done
Who are you ?
- Master's Degree
- Minimum 10 years of experience within pharmaceutical companies and working on CAPEX large projects.
- Dynamic person with strong value commitment & resilient
Strong Process Technical expertise - Fluent in English is mandatory. French is highly desirable.
- Good Knowledge of cGxP requirements
- GEP – Good engineering practice expertise
- Excellent communication skills (able to present to Management, Engineering office, User and others) and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
- Team player, Rigorous, Accountable, Involved, Proactive.
- Pragmatic to solve issues; solution oriented with a positive mindset
- Autonomous, fully acting at own's initiative.
- Broad Leadership experience for the management of internal and external resources.
- Ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Able to both take direction and mentor other team members
- Able to translate customers’ needs in technical requirements
- Open to travel to support UCB strategic international projects
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
