C&Q Engineer

Capgemini Engineering Team (ERD) is currently looking for C&Q Engineer for one of Pharmaceutical domain projects.

The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that: 


-Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities

-Qualification/Validation Master plans are up to date and established for all ongoing projects.

-Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment.

-Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.

-Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline.

-Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation).

-Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners.

-Coordination and oversight of external suppliers.

 Your profile

-Bachelor/Master’s degree in technical or natural sciences.

-A minimum of 5 years of working experience within pharma company in C&Q/CQV equivalent position

-Know-how of Qualification requirements according to cGMP regulations.

-Experience working with cross-department stakeholders.

-Know-how of quality assurance principles.

-Experience working in project teams and multiple projects in parallel.

-Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus.

-Excellent communication skills.

-Analytical thinking and problem-solving ability.

-Independent time management.


Language Capability

Fluent in both Japanese and English

Work Location/勤務地:

Tokyo or Osaka

Ref:

2022-JP-362

投稿日:

2022年04月19日

経験レベル:

Experienced (non-manager)

学歴レベル:

Bachelor's degree or equivalent

契約タイプ:

Permanent

勤務場所:

Osaka

Department:

Engineering