Sterilisation Cleaning Validation - Pharmaceutical

World leading Biopharmaceutical plant based in Holland have a contract requirement for an experienced STERILISATION VALIDATION ENGINEER.

Joining the Cleaning Validation Team and reporting to the Cleaning Validation lead, we are looking for a Sterilisation Validation Engineer to carry out the re-validation of different processes and equipment used by Manufacturing for the Upstream and/or Downstream production of products, ensuring full compliance with internal requirements and international standards.

This will include:

- Ensuring all aspects of Sterilisation Validation adhere to with global policies, procedures and guidelines and external regulatory requirements.
- Generating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and external auditors.
- Authoring, Review and/or Oversight of sterilisation validation-related procedures, protocols and technical reports required.
- Providing support and guidance for sterilisation related Root Cause Assessments.
- Providing impact assessments on sterilisation related events and anticipated changes.
- Driving improvements in sterilisation validation.

We are looking for candidates with sterilisation validation systems knowledge, including experience with Validation of steam in place (SIP) sterilisation, steam in autoclave sterilisation, dry heat sterilisation and sterilising filtration.

RESPONSIBILITIES WILL INCLUDE:

- Ensure Sterilisation Validation Plans and strategies are in alignment with global policies, procedures and guidelines and external regulatory requirements.
- Authoring, Review and/or Oversight of sterilisation validation-related procedures, protocols and technical reports required.
- Participate on investigation teams in the event of adverse sterilisation validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring sterilisation validation expertise and strong analytical and systematic problem solving skills;
- Knowledge of regulatory requirements within European and International codes, standards and practices.
- Support sterilisation validation needs to meet regulatory expectations and supply timelines.
- Ensures standardisation in processes and methodologies for validation activities across the site.
- Employ Strong change management and conflict resolution skills to make problems visible and to strive for continuous improvement collaboratively.
- Develop meaningful validation metrics/trending to enable continued drive for reliability and efficiency.
- Must demonstrate personal commitment with respect to working safely, healthy and environmentally friendly and all other guidelines.
- Ensures that documentation complies to GMP and EHS regulations.

QUALIFICATIONS:

- Degree/PHD in life sciences (Biotechnology or related) or comparable level through experience.
- A minimum of 5 years validation/manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification).
- SIP/Sterilisation/cleaning validation.
- Proven strong scientific, project & people management skills.
- Strong communicator and ability to build bridges between groups and organisations. Ability to create a team spirit.
- Knowledge of GMP guidelines and global validation expectations.
- Willingness to certify for or possessing Six Sigma Green Belt or Black belt degree.
- Passion for Lean and Continuous Improvement.
- Customer focused, process oriented and data driven.