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You've established your people management and leadership ability. Here is where you take it further. As a Cleaning Validation Manager you will lead 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.
In this role, you will lead all aspects of the development, execution, and maintenance of activities pertaining to validation of the Nucleic Acid Synthesis Division (NASD) site for Active Pharmaceutical Ingredient (API) manufacture. The validation manager coordinates and generates validation study documentation including protocols, plans, reports, and addenda while ensuring compliance with GMP requirements and current industry good practice. This position leads 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. Leads 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. Leads all aspects of 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 include being fully responsible for work completion and development of subordinates. Duties include hiring, training, compensating, scheduling, directing, mentoring, developing group enthusiasm and engagement with team-building exercises, making administrative decisions, budget management, and completion of performance appraisals. Lead 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, deals with concrete and abstract variables, and draw valid conclusions. Ability to apply sophisticated mathematical concepts to problem analysis and resolution utilizing correlation techniques, frequency distribution, permutations, and factor analysis. Ability to lead 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.