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Sr. Process Engineer Downstream

Switzerland, Switzerland

  • Salary: Dependent on Experience
  • Job type: Interim/Contract
  • Posted: 16/11/2018
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 3763

Job description

1 year contract in South-West Switzerland with option to extend

 

Job Summary (Primary function)
During the construction and facility startup phase you will be the process engineer responsible for process and equipment design and responsible to support the commissioning and qualification of DSP equipment and areas. This may include product and solution mixers, chromatography skid and packing, viral inactivation, normal filtration, viral filtration, UFDF.
During manufacturing operation, the process engineer will develop in an equipment and process engineering support role, mainly owning manufacturing scale equipment and process.


Essential Functions of the Job (Key responsibilities)


During the construction phase, you will mainly:
Lead process and equipment FMEA risk assessment, GMP reviews
Author, review and maintain comprehensive systems requirements (URS)
Lead the definition of DSP process equipment Functional Specifications
Actively participate in the definition and review of the Qualification Master Plan
Review Vendor Quality & Project Plans and Qualification/Test Plans
Actively participate in Regular calls, visits, status updates with process equipment manufacturers
Support FAT, SAT, IQ, Commissioning and OQ. Up to 25% European travel required
Support the development and implementation of process validation plans including protocols in cooperation with the Validation/Qualification Group
Assess Change Controls and deviations including any corrective actions arising during verifications
Revise and approve test reports
Support DSP equipment integration within the facility
Lead PQ activities

 

During the operation phase, you will mainly:
Author, review, approve, maintain life cycle (…etc) all required Standard Operating Procedures, Work Instructions, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
Act as a mentor to DSP manufacturing team members and lead by example to ensure integration of good engineering practices
Proactively propose problem resolution to process and DSP equipment
Assess events, deviations and non-conformances
Raise, investigate, assess and close Change Controls.
Prepare and deliver process and technology overview training
Actively participate in process and technology transfer

 

Qualifications (Minimal acceptable level of education, work experience, and competency)
BSc, Master or Engineering Degree in Pharma/Biotech engineering
Relevant experience in biotech industry related to cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation
Direct experience in FMEA, root cause analysis, and associated quality assessment tools
Typically minimum 5-7 years of experience
Ability to work in a fast paced – high regulated environment
French and English (Fluent)
Team work oriented mindset
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines