Celine Correia Email & Phone Number | Active support of DSP and Support routine production: • Provide technical and scientific expertise on process, process improvement • Troubleshooting, data analysis, investigation and problem solving to ensure production in required quality and delay. • Lead of change and deviation management (Trackwise system) as well as process improvements. Implementation of correctives and preventives actions. • Provide support and knowledge of automation system (DCS and MES) to support production teams and improve production recipes. • Strong involvement with production teams. Experience sharing for skills improvement, transfer of knowledge and information about process, problems, values and behavior. • Health authorities’ inspections (FDA, Swiss medic, etc.): deviation, change request, qualification report or strategies presentation. Preparation of production area, and visit with inspectors. • Writing and review of manufacturing documentation, Batch record review and documentation (sop) management. • Project management: increase of production capacity of the existing production unit. Capability of blocking point analysis and finding solution to integrate new equipment in a challenging environment. Coordination of qualification activities to ensure production restart within quality and delay requirements.Starting of a new Biotechnology plant. Design of the DSP part of the manufacturing process: • Ultrafiltration/Diafiltration equipments design and involvement in Chromatography skids design (technical drawings and 3D models) • Design and implementation of the final fill step • Supplier and Consultants management (technical and costs discussions) • Equipment qualification (FAT and SAT): involvement in testings and testing management. • Technical expert for troubleshooting, problem resolution and equipment optimisation • Coordination and execution of engineering runs Automation skills: • Definition and implementation of the process in the DCS and MES automation systems (Functional specification writing and review, parameters definition, alarms implementation) • DCS and MES automation systems qualification: involvement in testings and testing management. • Troubleshooting, problem resolution and optimisation GMP Production: • Validation run execution (process and cleaning validation activites) • Training and documentation management for DSP area Team management: • Coordination of production teams (organization, planning) and following of management courses. • Validation of a manufacturing process in order to get Health authorities approval to produce a monoclonal antibody. Organization of process validation studies at manufacturing scale. Writing of process validation reports (Cell culture & Purification parts). Working Words INC training. • Support to the manufacturing production according to GMPs for the DownStream Processing. Establishment of control charts to monitor the manufacturing process and handling of process deviations and “Out Of Expectation / Specification” (AQWA software).Writing of process transfer reports and validation protocols as a part of the transfer and validation of a manufacturing process in order to get Health authorities approval.Functional analysis of genes involved in the anaphase of mitosis in the filamentous fungus Ashbya Gossypii. Use of PCR, Electrophoresis, Fluorescence microscopy, processing of pictures with image J.

Celine Correia

Active support of DSP and Support routine production: • Provide technical and scientific expertise o...
Bulle, Bulle, Switzerland

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Celine Correia’s Email celine.correia@ucb.com

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Celine Correia’s Location Bulle, Bulle, Switzerland

Celine Correia’s Current Industry UCB

Celine Correia’s Prior Industry UCB Farchim | Novartis Pharma SAS | Biozentrum Basel

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Work Experience

UCB

Biotech Manufacturing Manager - DSP & Support area

2018-04-01 00:00:00 - Present

UCB Farchim

DSP Process Specialist

2012-06-01 00:00:00 - 2015-01-01 00:00:00

Novartis Pharma SAS

Process engineer

2010-09-01 00:00:00 - 2012-05-01 00:00:00

Biozentrum Basel

Internship in research

2008-06-01 00:00:00 - 2008-07-01 00:00:00

Skills

No Skills Available

Languages

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FAQ About Celine Correia

Celine Correia is located at
Bulle, Bulle, Switzerland

Celine Correia is a Active support of DSP and Support routine production: • Provide technical and scientific expertise on process, process improvement • Troubleshooting, data analysis, investigation and problem solving to ensure production in required quality and delay. • Lead of change and deviation management (Trackwise system) as well as process improvements. Implementation of correctives and preventives actions. • Provide support and knowledge of automation system (DCS and MES) to support production teams and improve production recipes. • Strong involvement with production teams. Experience sharing for skills improvement, transfer of knowledge and information about process, problems, values and behavior. • Health authorities’ inspections (FDA, Swiss medic, etc.): deviation, change request, qualification report or strategies presentation. Preparation of production area, and visit with inspectors. • Writing and review of manufacturing documentation, Batch record review and documentation (sop) management. • Project management: increase of production capacity of the existing production unit. Capability of blocking point analysis and finding solution to integrate new equipment in a challenging environment. Coordination of qualification activities to ensure production restart within quality and delay requirements.Starting of a new Biotechnology plant. Design of the DSP part of the manufacturing process: • Ultrafiltration/Diafiltration equipments design and involvement in Chromatography skids design (technical drawings and 3D models) • Design and implementation of the final fill step • Supplier and Consultants management (technical and costs discussions) • Equipment qualification (FAT and SAT): involvement in testings and testing management. • Technical expert for troubleshooting, problem resolution and equipment optimisation • Coordination and execution of engineering runs Automation skills: • Definition and implementation of the process in the DCS and MES automation systems (Functional specification writing and review, parameters definition, alarms implementation) • DCS and MES automation systems qualification: involvement in testings and testing management. • Troubleshooting, problem resolution and optimisation GMP Production: • Validation run execution (process and cleaning validation activites) • Training and documentation management for DSP area Team management: • Coordination of production teams (organization, planning) and following of management courses. • Validation of a manufacturing process in order to get Health authorities approval to produce a monoclonal antibody. Organization of process validation studies at manufacturing scale. Writing of process validation reports (Cell culture & Purification parts). Working Words INC training. • Support to the manufacturing production according to GMPs for the DownStream Processing. Establishment of control charts to monitor the manufacturing process and handling of process deviations and “Out Of Expectation / Specification” (AQWA software).Writing of process transfer reports and validation protocols as a part of the transfer and validation of a manufacturing process in order to get Health authorities approval.Functional analysis of genes involved in the anaphase of mitosis in the filamentous fungus Ashbya Gossypii. Use of PCR, Electrophoresis, Fluorescence microscopy, processing of pictures with image J.