Cleaning Validation Technical Specialist

Description:

This role requires close collaboration with various departments and offers the opportunity to lead cleaning programs for Upstream and Downstream equipment.

Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities. Knowledge of downstream purification processes such as ultrafiltration is desirable.

Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.

Good interpersonal skills coupled with proven ability to work effectively in a matrix organisation and in local group.

Ability to drive for results independently and adapt to rapidly evolving priorities.

Experience in cleaning validation and cleaning approaches to a multiproduct facility is advantageous.

Detail orientated and be proficient at technical writing.

Responsibilities

• Prepare and review relevant cleaning validation documentation including but not limited to protocols, reports, plans, risk assessments, technical/impact assessments.
• Provide input on cleaning processes and troubleshoot/support cleaning activities related to both commercial operations and new product introduction.
• Provide support for the technical services team during regulatory agency inspections.
• Identify operational process improvements using Lean Tools .
• Assist with the investigation of and operations deviations through the eQMS system, engaging with all relevant personnel and functions as appropriate.
• Participating in technical projects, inclusive of process optimisation projects.
• Responsibility for Change Management and Deviation Management.
• Ability to manage competing priorities to ensure timely delivery of tasks.

Qualifications

• Minimum of three years’ experience in cleaning validation, preferably in bulk drug substance manufacturing.
• Experience in lean processing is an advantage.
• Experience in preparation of routine documentation to GMP standard
• Experience working with digital tools and applications (MS Office, Adobe etc)
• Ability to read, comprehend and prepare applicable documentation required