Laboratory Systems and Validation Manager

About the role

This is a full-time position reporting to the Senior Manager of Quality Control. The position involves leading technical operations related to quality control of the Company’s products according to Standard Operating Procedures (SOPs) and in compliance with current Good Manufacturing Practice (cGMP) as required by the U.S. Food and Drug Administration (FDA).

Responsibilities

• Qualify testing equipment
• Validate laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines.
• Perform system administration functions for QC software systems, including data backup.
• Validate/verify quality control methods to ensure active pharmaceutical ingredients are tested and manufactured in accordance with cGMP, SOPs, and safety requirements.
• Lead and assign technical tasks/duties associated with commissioning and qualification of laboratory equipment and software validation; analytical method optimization, transfer and validation / verification; and product lifecycle improvement projects.
• Provide leadership for cross-functional teams, including training, coaching, and mentoring.
• Champion cGMPs, safety, and workplace activities and help develop and meet QC compliance and safety goals.
• Respond to any observed laboratory or safety issues and take action as appropriate.
• Work closely with Engineering/Maintenance, Quality Assurance, Manufacturing and R&D teams.
• Support QC out-of-specification (OOS) investigations as needed to determine product impact, root causes and identify corrective and preventive actions (CAPA) to prevent recurrence.
• Provide technical expertise to resolve equipment, software or testing issues and interact with colleagues to ensure QC testing requirements are met.
• Draft, revise and review technical protocols, reports, standard operating procedures, and worksheets, ensuring compliance with cGMP and Good Documentation Practices (GDP).
• Timely and compliant oversight of the software development lifecycle for validated systems.
• Ensure QC metrics and business systems records are properly developed and maintained.
• Counsel employees to promote their success and manage employee performance issues as needed.

Qualifications

• Bachelor's degree from an accredited four-year college or university in a chemistry, microbiology or other technical field and 5+ years of demonstrated experience in FDA cGMP compliance environment in a QC laboratory.
• 2+ years of demonstrated experience in team management/development or project leadership is required.
• Demonstrated leadership skills and the ability to uphold regulatory, company, and customer standards.
• Proficient with complex mathematical calculations, technical writing, interpersonal and communication skills (written and verbal).
• Capable of working well with cross-functional teams in a dynamic setting to achieve company goals.
• Works well in high pressure situations.

Pay

The expected pay range for this position is $120,000 - $162,500 annually. Smithfield Foods provides pay ranges that reflect its good faith estimate of the salary or hourly wage the company reasonably expects to pay for a position at the time of hire. Individual compensation will be determined based on several factors, including but not limited to, the scope and responsibilities of the role, location of the position, the candidate’s qualifications and experience, internal equity, external market pay for comparable positions and budget considerations.

Benefits

Smithfield Foods offers a comprehensive benefits package that includes health insurance, retirement plans, paid time off, and more. Relocation package available.

EEO Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.