Validation Engineer

Job Description

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

Leads and performs cleaning validation and equipment commissioning and validation engineering duties to support initial start-up and qualification of a new Active Pharmaceutical Ingredient (API) manufacturing facility at Agilent Technologies Nucleic Acid Solutions Division in Frederick, Colorado. Primary responsibilities include the planning, execution, reporting, and communication of validation activities compliant with pharmaceutical Good Manufacturing Practices (GMP).

Essential duties and responsibilities:

• Generate, review, and execute documentation for commissioning, qualification, and validation studies (IQ, OQ, PQ) on equipment, facilities, and computerized systems ensuring compliance with cGMP.

• Support the validation schedule by collaborating with manufacturing, engineering, quality control (QC), and quality assurance (QA) teams for activities.

• Support the generation and execution of cleaning cycle development and validation activities, such as: sprayball coverage testing, reports, visual inspections, protocols, and standard operating procedures (SOPs).

• Lead validation contract staff to complete validation activities.

• Assist with validation planning and risk assessments associated with validation activities.

• Investigates and conducts troubleshooting and root cause analysis of validation related incidents and deviations.

• Resolve CAPA's, nonconformances, protocol incidents, and change controls related to validation protocols.

• Generate data and reports for the validation periodic monitoring and re-qualification programs.

• Assist with audits, when related to validation.

Qualifications

• Bachelor’s or Master’s Degree or equivalent education/and or experience (complemented by a post-graduate and/or certification/license)

• 4+ years' practical experience in validation in a GMP environment

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Knowledge of system validation life-cycle concept.

• Familiarity/experience with working on capital projects.

• Ability to communicate to a group of individuals through oral and/ or written materials.

• Functional, hands-on experience with pharmaceutical manufacturing processes, equipment, and quality systems.

• Functional, hands-on experience with cGMP guidelines as well as international regulations pertaining to the production of APIs and drug products,

• Functional, hands-on experience with and ongoing technical competence and engagement in the field of Cleaning Development and Cleaning Validation.

• Functional, hands-on experience with computer system validation, including data integrity and 21 CFR Part 11 requirements.

• Technical writing ability with 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 manage multiple tasks and priorities and establish short and long-term planning horizons to complete these duties.

• Ability to work effectively as a team to accomplish deadlines and objectives yet make independent decisions on various tasks.

• Ability to lead engineering validation projects and solve complex problems using in-depth experience.

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least March 12, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $97,920.00 - $153,000.00/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: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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 diversity in the workplace 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 [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

No

Shift:

Day

Duration:

No End Date

Job Function:

Manufacturing