Validation & Sanitation Manager

Merical, Llc

Not Interested
Bookmark
Report This Job

profile Job Location:

Anaheim, CA - USA

profile Yearly Salary: $ 100000 - 120000
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

NO EXTERNAL RECRUITERS PLEASE

**No Sponsorship/Transfer Available**

Company Summary:

For over 60 years MeriCal has been at the forefront of innovation in the dietary supplement industry delivering custom manufacturing and packaging solutions with passion and precision. With state-of-the-art facilities in Southern California and Ogden UT we transform ideas into high-quality productsfrom research and development to the finished products. Our team with over 230 years of combined experience is dedicated to crafting exceptional gummies probiotics tablets capsules chewables and powders using clinically backed ingredients. At MeriCal we dont just meet expectationswe exceed them every time. Join us and be part of a dynamic forward-thinking team shaping the future of nutrition!

The Opportunity:

The Sanitization Lead is responsible for developing executing and managing the sanitation and all equipment cleaning validation programs. This position ensures that all cleaning hygiene environmental monitoring pest control and cleaning validation processes are compliant with company local state and federal food sanitation and GMP standards customer requirements and applicable third-party certification.

The Manager oversees the planning coordination and execution of cleaning equipment and cleaning validation activities including IQ/OQ/PQ. They serve as the primary contact for sanitation and validation matters during regulatory inspections audits and internal reviews. The manager also collaborates closely with cross-functional teams - such as Quality Assurance Engineering Production and Regulatory Affairs to ensure operational excellence risk mitigation and continuous compliance cGMP standards.

The roles leads a team of sanitation and janitorial professionals drives continuous improvement initiatives and ensure that all site personnel are trained and held accountable for maintaining high standards in cleanliness hygiene and equipment/cleaning addition to day-to-day execution the Sanitation Validation Manager will contribute to strategic planning and long-term site readiness related to validation lifecycle management and sanitation infrastructure.


What Youll Do:

  • Disassemble clean sanitize processing equipment such as kettles CFAs cooling tunnels incline conveyors z elevators bottling and packaging equipment scoops and all other machines components and parts as directed by the Sanitation Supervisor.
  • Lead and enforce the policies and procedures surrounding the food safety sanitation hygiene environmental monitoring and pest control programs.
  • Ensure facility compliance with all applicable local state and federal sanitation and cGMP regulations (21 CFR Part 111/117 and 21 CFR Part 210/211).
  • Participates in internal/external audits.
  • In instances of violations develops/coordinates a cross-functional plan to correct the issues found.
  • Processing a keen understanding of industry laws then consult with management to address compliance issues and make recommendations to improve processes.
  • Develop and maintain sanitation SOPs and the Master Sanitation Schedule (MSS) across all manufacturing shifts and areas.
  • Keep detailed records of all sanitation-related activities and issues such as inspections and violations also noting how and when each situation was resolved.
  • Develop and conduct cleaning validations on production equipment.
  • Develop Validation Master Plan process flow diagrams and test cases in compliance with company standards current industry standards and regulatory expectations.
  • Ensure cleaning validation protocols include visual inspection criteria swab/surface testing (e.g. TOC HPLC) and worst case scenario evaluations (e.g. allergen active ingredient carryover).
  • Chemical management.
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations.
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of problems.
  • Write review and approve validation protocols and reports; ensures adherence to validation strategies aligned with product risk profiles.
  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
  • Create populate or maintain databases for tracking validation activities test results or validated systems.
  • Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols.
  • Direct validation activities such as protocol creation or testing.
  • Maintain sanitation programs for all sites.
  • Maintain pest control for all sites.
  • Maintain an environmental monitoring programs for all sites.


What Youll Bring:

  • Bachelors degree within Food Science or Microbiology background is preferred. or equivalent knowledge and experienced gained from working within the field.
  • Minimum of 5-7 years of experience in regulated manufacturing environment with at least 3 years in a supervisory or management role.
  • Hands-on experience with FDA- regulated manufacturing - specifically 21 CFR Part 111 (Dietary Supplements) and 21 CFR 210/211 (OTC Pharmaceuticals).
  • Demonstrated experience with cleaning validation and equipment qualification in a high-compliance environment.
  • Strong knowledge of environmental monitoring GMPs HACCP CAPA and change control processes.
  • Training and Certification of Food Safety Sanitation and Validation in a GMP environment or FDA regulated industry.


The Perks:

  • No-cost vision insurance (yes you read that right!) employer-paid life insurance paid company holidays generous paid time off sick leave employee assistance program and a comprehensive wellness program.
  • Affordable medical and dental insurance plans tailored for you and your dependents.
  • Exceptional supplemental benefits including Accident Critical Illness Hospitalization indemnity plans and pet insurance.
  • 401(k) matching plan and more!

A reasonable estimate of the current base pay range for this position is $100000 to $120000. The compensation offered may vary depending on the candidates geographic region job-related knowledge skills and/or education.

MeriCal is an equal opportunity employer and is committed to providing a workplace that is inclusive and free of discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status protected veteran status or any other characteristic protected by law. We encourage individuals of all backgrounds to apply. We believe in creating a diverse and inclusive workplace where all employees feel valued and respected and where differences are embraced as strengths. We are dedicated to fostering an environment that promotes equality and celebrates diversity.

Qualified applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and/or certain state or local laws. Please contact if you need an accommodation due to a disability to complete an application job interview and/or to otherwise participate in the hiring process. This email does not respond to non-accommodations related requests.

MeriCal uses E-Verify to confirm authorization to work in the United States. For more information on E-Verify please visit the following website: more information about the categories of personal information we collect from you and how we use sell and share that information please see our Privacy Notice for California Contractors and Privacy Notice for California Employees.


Required Experience:

Manager

NO EXTERNAL RECRUITERS PLEASE **No Sponsorship/Transfer Available**Company Summary:For over 60 years MeriCal has been at the forefront of innovation in the dietary supplement industry delivering custom manufacturing and packaging solutions with passion and precision. With state-of-the-art facilities...
View more view more

Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing