Jobdescription
Commissioning Qualification Validation
Engineer
For our Client in Visp we are
searching for a Commissioning Qualification Validation Engineer
(CQV) to carry out a variety of tasks related to the validation of
equipment and facilities.
Key
Responsibilities:
CQV
validation activities including but not limited to: Facilities,
Utilities, Validation Life Cycle, Execution, Technical
Documentation, Process, GAP Analysis and Risk
Assessment.
Coordination of
the installation of
equipment.
Drafting of the
IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the
results according cGMP
requirements.
Execution of
IQ/OQ and PQ for equipment, systems and
utilities.
Prepare
validation documentation deliverables including URS, DQ, FMEA, Risk
Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ,
PQ).
Work to identify
efficiencies in the validation program approach and apply lessons
learned and stay informed of industry regulatory changes as it
applies to equipment and 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.
Qualifications:
Education
Required: Bachelor’s Degree in Science or Technical
field.
Advanced Level Pharma
Industry minimum 5 years
experience.
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.
German mandatory
(English a real plus)