Process Engineer

FUNCTION DESCRIPTION
-To facilitate the sites entry into routine operations ensure the implementation of validation principles or adapted one, also including technical topics to facilitate (PT)
-Acts as key account holder for any validations and technical topics and provide any information to the project leader (SPOC)
-Ensure the continuous validation and technical life cycle support for External Support project (ES)

KEY RESPONSIBILITIES

*Based on the project portfolio, support the overall activities deployment (routine operation, field, technical support, and validation) for primary and secondary process.
*Act as validation and technical coordinator for CMO, International project (providing all technical informations to the SPOC product transfer)
*These several supports will cover the following expertise, media preparation, primary process (upstream and downstream processes) secondary processes (formulation, filling, visual inspection, CCIT, Packaging, aseptic processes,…) transversal support (HVAC, environmental monitoring, CIP, SIP, clean utilities, Extractable & Leachable, bioburden, homogeneity, inactivation, filters, cartridges life time,…) and providing the risk assessment support
*To escalate any potential issues to the PT and ES project leader/SPOC.*To deploy,adapt the latest validation standard in accordance with the CoE team requirements and provide to the Expert any deployment issues
*To coordinate the QC validation of equipment (IQOQ) and transversal equipment PQ (Autoclave, clean utilities, GMP washer, Incubators, thermostatic rooms,…)
*Ensure the availability of the all documentation required to support the validation (URB, BD, FAT, SAT, IQ, OQ, VMP, PQ, VSR, Continuous Validation, risk assessment, ….). from the donor sites or from the existing library

Complexity:

*Degree of uncertainty: There will be much uncertainty and changes due to the outcome of external business negotiations, of technical challenges, of the evolution of the vaccine environment and of the judgment by Regulatory Authorities. Business opportunities need a strong reactivity and sense of urgency.
*Complexity and human relations: The incumbent must operate cross-functionally in a global environment, build and sustain personal relationships at 360°, face cultural differences. Management of contact with third parties
*Projects and new products introduction complexity: Projects with respect to nature of products (bacterial vaccines, viral vaccines, adjuvants, diluents), process steps (bulk, coupling, formulation, filling, packaging) and global support activities (RA, logistics, validation, raw mat, procurement, …)

PREREQUISITES
Education :
*University degree in the Pharma and/or Biotechnology field with experience in Primary or secondary manufacturing of vaccines/ Project Management/ Validation (> 5 years)
*Scientific and technological know-how related to vaccine primary and secondary manufacturing operations.
*Expertise in Validation (V-cycle) and technical (Maintenance, C&M and requalification)
*Strong knowledge of aseptic operations
*Knowledge of international regulations (FDA, PIC's, WHO, Eudralex and local cGMP)
*Flexibility to face rapidly changing environment in validation and technical environment.
*Work in a matrix organization.
*Project management skills (planning)
*Skills to report internally and externally.