Cleaning Validation Specialist

2 days ago

Dublin, Ireland Cpl Healthcare Full time

CLEANING VALIDATION SPECIALIST

Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term contingent contract at their state of the art plant in Dublin Grange Castle.

Job Purpose:

Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team supporting new product introduction and cleaning validation activities across the site. A critical enabler to product manufacture is a robust, and audit ready cleaning validation program that allows the plant to operate at full capacity and complete product changeover in a safe and efficient manner. This is an ideal development opportunity to join a dynamic team who provide cleaning validation support to the manufacturing areas and support process transfer and new product introduction projects into the manufacturing facilities.

The cleaning validation specialist is responsible for providing technical support for cleaning validation activities and strategies for equipment used in the manufacture of drug substances and drug products in accordance with regulatory requirements and company manufacturing standards. The role focuses on cleaning validation execution, cleaning validation design, cleaning monitoring and troubleshooting, including leading and resolving technical issues and manufacturing investigations relating to cleaning processes, supporting new product introductions, facility design and equipment design specifications.

The role will provide the opportunity to develop technical, communication and project management skills through interaction and collaboration with multiple departments (Operations, Quality, Engineering) that support the site cleaning validation program. The role may entail specialization and training in process science/engineering to meet overall site business needs for technical support.

Job Responsibilities:

- This is a non-laboratory based role supporting the site cleaning validation program.
- Generate, review and approve documentation for cleaning validation including protocols, summary reports, validation plans, and supporting documents.
- Cleaning validation execution, including cleaning monitoring.
- Generate, review and approve validation deviations and ensure successful implementation of corrective actions.
- Write impact assessments in support of investigation closures.
- Provide expertise for troubleshooting and resolution of problems.
- Co-operate with multifunctional teams to deliver projects on time.
- Support bench scale studies such as cleaning efficacy, recovery studies, solubility.
- Develop and maintain cleaning validation strategies including product and equipment grouping strategies.
- Develop and maintain cleaning acceptance criteria for manufacturing equipment.
- Identify and drive continuous improvements within the group to ensure streamlined and efficient Cleaning Validation.
- Technology transfer for new processes and new product introduction.
- Regulatory inspection support and close-out of regulatory follow-up measures.
- Technology transfer of new processes or process changes.

Skills:

- A minimum of 2 years cGMP industrial experience with good technical writing skills.
- Minimum 12 months of Cleaning Validation experience.
- Demonstrated aptitude for technical learning and problem solving.
- Continuous improvement mindset to drive positive change.
- Proactive, persistent, and good communication skills.

Education:

Third level qualification in Science or Engineering is required. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).

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