Senior CQV Engineer

Senior Commissioning, Qualification & Validation (CQV) Engineer | GMP Environment

 

Job Description

A pharmaceutical organisation is seeking an experienced Commissioning, Qualification & Validation (CQV) Engineer to carry out a variety of tasks related to the validation of equipment and facilities within a cGMP-regulated environment. The scope of the role includes coordination during equipment installation, drafting IQ/OQ/PQ protocols, execution of IQ/OQ/PQ activities, and documentation of validation results in accordance with cGMP requirements.

In this role, you will be involved in validation activities across facilities, utilities, and systems, covering the full validation lifecycle. Responsibilities include preparation of technical documentation, execution of validation protocols, risk assessments, GAP analyses, and support of Engineering and Quality activities. You will contribute to continuous improvement of validation programmes, apply lessons learned, and remain informed of regulatory and industry changes relevant to equipment and facility validation.

 

Essential Requirements

· Bachelor’s degree in Science or a Technical field

· Minimum 5 years’ experience in the pharmaceutical industry at an advanced level

· Proven experience in Commissioning, Qualification, and Validation (CQV)

· Hands-on experience preparing and executing IQ/OQ/PQ for equipment, systems, and utilities

· Strong knowledge of the validation lifecycle and cGMP requirements

· Experience producing validation documentation, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and validation protocols (IQ, IOQ, OQ, PQ)

· Ability to write clear and compliant validation reports

· Experience performing GAP analyses and risk assessments

· Experience supporting Quality Systems activities, including Document Management Systems, Change Control, Non-Conformities, and CAPAs

· Excellent technical writing skills with strong attention to detail

· Strong organisational and time management skills

· Strong written and oral communication skills with the ability to work cross-functionally

· German language proficiency (mandatory)

· English language skills (a strong plus)

 

Preferred Requirements

· Experience identifying efficiencies and improvements within validation programme approaches

· Experience applying lessons learned and monitoring regulatory and industry changes related to equipment and facility validation

· Experience writing and/or revising procedures related to Engineering and validation activities

· Experience supporting validation, requalification, and maintenance programmes in collaboration with Engineering teams

 

Practicalities

Start Date: ASAP

Location: 100% on-site

Team: Works closely with Engineering and Quality teams

Scope: Equipment, systems, utilities, and facilities validation in a pharmaceutical environment

 

Interested? Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.