Validation Engineer
Our client, a well-established global manufacturer of pharmaceuticals is looking to recruit a Validation Engineer to report directly to the Head of Quality. The Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments.
Responsibilities
- Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning
- Manage the validation requirements of the business and third party suppliers and CMO’s
- Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
- To maintain and take responsibility for the cleaning validation strategy
- To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
- Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications
- Coordination of the execution of Validation in accordance with protocols by Production, QC and R&D teams
- Establishing, implementing and directing validation and revalidation activities
- Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate
- Reviewing and managing Change Control Forms for Validation implications
- Reviewing and managing Non-Conformances for Validation Implications
- Updating existing quality documentation related to validation activities
- Identifying training requirements in support of validation
- Ensuring completion of validation protocols
- Carry out Internal Audits as required
- Responsible for the execution of Risk Assessments or Investigation reports relative to the role
- Maintaining validation documentation system
- Required to Lead cross functional teams providing knowledge in resolution in any technical issues
- Assisting in the preparation and hosting of associated regulatory and customer audits
- Knowledge of Process and Cleaning Validation
- Ability to perform in external audits
- Health & Safety requirements (e.g., Manual Handling Training)
- To take reasonable care for their own safety, health and welfare at work and that if aby other person that may be affected by their actions or omissions while at work
- Adheres to safety regulations by ensuring correct usage of PPE in laboratory and production areas
- Reports to the supervisor or health and safety representative any defects in plant, equipment, place of work, system or work which might endanger safety, health or welfare of themselves or any employee on site
Qualifications
- Minimum Bachelor of Science or Engineering
- B.Sc. / M.Sc. in Scientific Discipline
- Minimum 2 years relative experience in a similar position
- HPRA / USFDA Experience
- Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
For more information, please email [email protected]
