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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