Sr. Cleaning Validation & Sterilization Consultant

• Development of cleaning revalidation program
• Create cleaning cycle development strategies for a variety of equipment including: process vessels, clean-in-place systems, packaging equipment, parts washers, and production facilities.
• Write validation protocols and reports in support of the site’s cleaning validation program
• Investigate and troubleshoot problems which occur during cleaning
• Responsible for planning and execution of onsite cleaning validation programs compliant with the regulatory requirements.
• Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval
• Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
• Develops and authors change controls for cleaning process or equipment changes
• Maintain an up-to-date knowledge of validation requirements, practices, and procedures
• Write validation plans and risk assessments related to specific projects and facilities
• Write and review policies and procedures (SOPs)
• Facilitate the development of user requirement specifications and operational SOPs for equipment.
• Perform risk assessment and gap analysis for site cleaning programs.
• Perform cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
• Leads continuous improvement activities related to cleaning and changeover optimization
• Responsible for identify appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies
• Other duties as assigned

• Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
• Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities
• Thorough knowledge of cGMP/FDA regulations
• Ability to drive change and motivate others toward a common vision
• Ability to lead teams that are not direct reports
• Demonstrated facilitation, problem solving, and analytical skills
• Understanding of cGMP regulation and quality management systems for pharmaceutical operations
• Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management
• Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
• Must have strong ability to organize and manage multiple tasks in a fast-paced environment.
• Team player

• 5+ years of experience in a regulated manufacturing industry.
• Demonstrated understanding and knowledge of reviewing and writing technical documents such as risk assessments and validation documents
• Strong knowledge of cGMP/FDA regulations
• Strong communication skills (oral and written)
• Ability to organize and manage multiple tasks in a fast pace environment
• Attention to detail
• Demonstrated problem solving and analytical skills
• Strong interpersonal skills/Team Player
• High degree of personal integrity
• Strong computer and mathematical skills
• Self-starter, work without close supervision

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