Description
What's it like to work at Agilent in Manufacturing?
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Cleaning Validation Manager.
You've established your people management and leadership ability.
Here is where you take it further.
You will manage a team of validation engineers, driving their performance in the design of validation policies and processes, to improve quality, production and profitability.
You will also have the opportunity to develop strategies and multi-year implementation plans for new product introductions and continuous improvement.
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.
This position manages validation activities and schedules via close matrix interaction with engineering, production, facilities, Information Technology (IT), Quality Control (QC) and QA personnel while providing guidance for validation items.
Manages the validation life cycle to ensure the ongoing validated status of systems and readiness for pre-approval inspections, client visits, and regulatory inspections.
This position is responsible to defend validated systems during customer audits and regulatory inspections.
ESSENTIAL DUTIES AND 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.
MANAGERIAL RESPONSIBILITIES
Managerial responsibilities include being fully responsible for work completion and development of subordinates.
Duties include hiring, training, compensating, scheduling, directing, coaching, developing group enthusiasm and engagement with team building exercises, making administrative decisions, budget management, and the completion of performance appraisals.
Manage and direct contract resources in efforts to complete validation tasks.
KNOWLEDGE, SKILLS, AND ABILITIES
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to communicate to a group of individuals through oral or written forms.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.
Ability to manage multiple tasks and priorities and establish short and long-term planning horizons to complete these duties.
Knowledge of cGMP guidelines, international regulations as well as current good industry practice pertaining to the production of APIs and drug products.
Guidelines include ICH Q7, CFR, USP and the EudraLex.
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.
Qualifications
Bachelors or Master Degree or University Degree or equivalent plus directly relevant experience as a manager, supervisor and/or individual contributor with 8+ year of experience.
Requires proven skills in leading/managing the execution of processes, projects and tactics.
Agilent Technologies Inc.
is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Additional Details
This job has a full time weekly schedule.Travel Required:
OccasionalShift:
DayDuration:
No End DateJob Function:
Manufacturing