Validation Manager

Agilent Technologies • Frederick, CO

101d • $124,160 - $194,000

About The Position

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. The Cleaning Validation Manager will manage a team of validation engineers, driving their performance in the design of validation policies and processes, to improve quality, production and profitability. This position is responsible for all aspects of the development, execution, and maintenance of activities pertaining to validation of Nucleic Acid Synthesis Division (NASD) site for Active Pharmaceutical Ingredient (API) manufacture. The validation manager oversees and generates validation study documentation including protocols, plans, reports and addenda while ensuring compliance with GMP requirements and current industry good practice.

Requirements

• Bachelors or Master Degree or University Degree or equivalent plus directly relevant experience as a manager, supervisor and/or individual contributor with 8+ years of experience.
• Proven skills in leading/managing the execution of processes, projects and tactics.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Knowledge of manufacturing processes and methods for cost-reduction, quality improvements, and efficiency.
• Knowledge in the fields of science and engineering with the ability to apply these concepts to define problems, collect data, establish facts, deal with concrete and abstract variables, and draw valid conclusions.
• Ability to apply advanced mathematical concepts to problem analysis and resolution utilizing correlation techniques, frequency distribution, permutations, and factor analysis.
• Knowledge of cGMP guidelines, international regulations as well as current good industry practice pertaining to the production of APIs and drug products.

Nice To Haves

• Technical knowledge of assays utilized for the testing of oligonucleotide APIs and raw materials.
• Knowledge of and ongoing technical competence and engagement in the field of Validation.

Responsibilities

• Generates, revises, reviews and approves documentation for validation studies ensuring compliance with QA and cGMP systems.
• Oversees the execution of validation studies for equipment, instruments, utilities, processes, cleaning, and control systems through commissioning, IQ, OQ, and PQ phases.
• Review and approval of reports for completed IQ, OQ, and PQ validation studies.
• Responsible for the generation, maintenance, and oversight of the Master Validation Plan (MVP) and all related documentation.
• Responsible for the generation, maintenance, and oversight of Validation Risk Assessments for the medium and large scale GMP facilities.
• Responsible for pre-approval inspection readiness for all validated systems at NASD.
• Responsible to present and defend validated systems during customer audits and regulatory inspections.
• Coordinates validation schedules with manufacturing, engineering, quality control, quality assurance and IT to facilitate smooth and efficient validation within the scope of the overall projects.
• Review and approval of qualification incident reports related to validation studies.
• Responsible for site training on the validation program.
• Responsible for oversight and execution of other fundamental activities associated with administration of the validation program.
• May act as a delegate for Senior Director, Engineering and Facilities for validation program decisions.

Benefits

• Full-time equivalent pay range for this position is $124,160.00 - $194,000.00/yr plus eligibility for bonus, stock and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree