Validation Manager

POSITION SUMMARY:

The Validation Manager works with Quality, Manufacturing, Maintenance, Sanitation, and Regulatory personnel to perform manufacturing process and cleaning process validations and qualification of manufacturing equipment. Job duties include developing validation plans, designing validation protocols, executing the protocols, and summarizing the validation works with  validation reports. This position requires strong communication skills, computer skills, and experience in management.

The position reports to the Vice-President of Quality Systems.

MAJOR FUNCTIONS & RESPONSIBILITIES:

• Lead the validation activities with protocol design, and execution of the protocol for OTC products manufacturing process and cleaning process validations.


• Lead the validation activities with protocol design, and execution of the protocol for dietary supplements and food products cleaning process validations.


• Lead validation, verification, and qualification activities on manufacturing equipment and control systems validation, verification, and qualification.


• Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities in compliance with regulatory requirements.


• Design, review, and approve protocols as well as reports to deliver a complete package of qualification documents.


• When validation activities are outsourced, you will manage the activity and monitor KPIs to assure the performance and cost effectiveness.


• Coach and grow validation team members including enhancing their performance, career development, sharing knowledge and experience, conduct training, and adhere to regulatory compliance.


• Design overall validation strategy for the site as well as act as a technical lead.


• Write and review GMP documents including cleaning and validation procedures, SOPs, and training documentation.


• Work closely with Manufacturing and Scheduling to build a qualification schedule that delivers minimum interruption to manufacturing output.


• Work in a safe manner, always ensuring full compliance to HS&E policies.


• Take initiatives in continuous improvement of the manufacturing facility.


• Actively maintaining up to date developments, standards, and operating practices within the Food, Dietary Supplement, and pharmaceutical industries.


• Conduct root cause analysis to facilitate and initiate corrective actions and preventive actions (CAPA) with manufacturing operations management.


• Develop and write standard operating procedures (SOPs) ensuring compliance with the company’s policies and FDA regulations.


• Adhere and enforce current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), safety, company rules, SOPs, and policies.


• Willing to accept additional assignments and responsibilities by senior management.

 REQUIRED EDUCATION / WORK EXPERIENCE / SKILLS:

• Prefer a 4-year college degree (BS or BA) in science (i.e. Biology, Chemistry, Biochemistry, Microbiology, Biotechnology, and/or Engineering etc.). Engineering experience is preferred.


• At least 5 years of work experience in pharmaceutical, personal care, biotechnology, dietary supplements, food and/or beverage industry with the knowledge of Regulatory Compliance on equipment validation, cleaning validation, and manufacturing process validation.


• 1-2 years supervisory experience preferred.


• Good working knowledge of 21 CFR Part 111, 21 CFR Part 117, 21 CFR Part 210 & 211.


• Good knowledge of Hazard Analysis and Critical Control Points and other food safety programs, quality assurance and manufacturing principles and procedures.


• Ability to communicate effectively in writing and verbally with employees at all levels of the organization.


• Ability to manage and prioritize multiple projects using effective organizational skills and judgment in an environment of frequent new customer products.


• Ability to use Microsoft Office applications; specifically using Word to create and modify documents, Excel to record data and calculate results, and PowerPoint to prepare training documents.

OTHER REQUIREMENTS:

• The role-holder will be required to operate across the facility including GMP environments which requires careful attention to details, and closely following applicable SOPs.