Cleaning Validation Specialist

Summary of Role:
Ensure compliance with GMP standards by developing, executing, and documenting cleaning validation activities in a pharmaceutical manufacturing environment. This role collaborates with production, quality assurance, and regulatory affairs to maintain contamination control and regulatory compliance.

Responsibilities:

• 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 identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies
• Other duties as assigned

Location: Albany, NY

Education: Bachelor's degree in Engineering or a Scientific field.

Preferred Qualifications:

• 3+ 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

Skill:

• Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
• 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
• 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.

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned