CAPA Project Engineer

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Quanta Consultancy Services
Place:
Paris
Date:
03/13/2015
Country:
flag_no United Kingdom
project ID:
867677

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Project Engineer - CAPA

Our global pharmaceutical client is currently undergoing a site transformation program from chemical to biopharmaceutical production. They are looking for additional support for their biopharmaceutical production in the area of CAPA execution to help close out current deviations. They seek proactive, self-motivated and team orientated individuals who enjoy hands on work.

Location: Paris region, France
Duration: 6 months

Role and Responsibilities:

• Take ownership of assigned CAPAs, work through execution to sign off.
• Work with colleagues and interdisciplinary team members to find correct solutions to deviations/ CAPAs.
• Execute solution and complete relevant documentation. Ensure sign off is obtained.
• Support various small engineering projects including new equipment, upgrades and maintenance including FAT/SAT, qualification, commissioning and validation.
• Support with the writing of technical and functional specifications for equipment.
• Help set up GMP and FDA compliant systems and processes.

Requirements:
• Pharmaceutical Project or Process Engineering background.
• Previous experience of execution of CAPAs/Deviations.
• Experience working in a biotech environment essential.
• Experience of working on small projects including testing, installation and CQV desired.
• Experience in biotech environment with the following equipment desirable:
o Bioreactors
o Fermenters
o Centrifuges
o Chromatography
o Primary Packaging (bottling)
• Able to communicate and build relationships with stakeholders from various different backgrounds
• Fluent French and English language required.