Validation Manager
Share
Job Location:
Frederick, MD - USA
Monthly Salary:
$ 124160 - 194000
Posted on:
21-09-2025
Vacancies:
1 Vacancy
Job Summary
Job Description
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. Applications for this job will be accepted until at least September 26 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $124160.00 - $194000.00/yr plus eligibility for bonus stock and benefits. Our pay ranges are determined by role level and location. Within the range individual pay is determined by work location and additional factors including job-related skills experience and relevant education or training. During the hiring process a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals regardless of personal characteristics are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex pregnancy race religion or religious creed color gender gender identity gender expression national origin ancestry physical or mental disability medical condition genetic information marital status registered domestic partner status age sexual orientation military or veteran status protected veteran status or any other basis protected by federal state local law ordinance or regulation and will not be discriminated against on these bases. Agilent Technologies Inc. is committed to creating and maintaining an inclusive in the workplace where everyone is welcome and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility please email or contact 1-. For more information about equal employment opportunity protections please visit Required: OccasionalShift:
DayDuration:
No End DateJob Function:
ManufacturingRequired Experience:
Manager
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
