Commissioning Engineer

vor 2 Wochen


Visp, Schweiz PE Global Vollzeit

Senior Recruitment Consultant at PE Global

PE Global is recruiting for a CQV Engineer on behalf of our pharmaceutical client in Switzerland. This is an initial 12-month contract fully onsite role.

Summary:

The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities.

The scope of activities includes:

  • the coordination on the installation of equipment,
  • drafting the IQ/OQ/PQ protocols,
  • execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.

Key Accountabilities:

  • The CQV Engineer will be involved in all validation activities including but not limited to:
  • Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
  • The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
  • Execution of IQ/OQ and PQ for equipment, systems and utilities.
  • Write reports of completed validation activities.
  • Work to identify efficiencies in the validation program approach.
  • Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
  • Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA's.
  • Writing and/or revising procedures applicable to the Engineering activities.
  • Support the Engineering group to prepare the validation, requalification, and maintenance program.
  • Perform other duties as assigned.

Education Required:

Bachelor's Degree in Science or Technical field.

Work Experience:

Advanced Level Pharma Industry 5-10 years.

Skills:

  • Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
  • Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
  • Excellent organizational and time management skills.

Interested candidates should submit an updated CV.

Please call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to paul.wheatley@peglobal.net

Note: Our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Engineering, Science, and Information Technology

Industries

Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research

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