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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.
Responsible for the execution of plant validation activities at the Active Pharmaceutical Ingredient (API) manufacturing site of Agilent Technologies Nucleic Acid Solutions Division. Generating and reviewing validation study documentation including protocols, requirements specifications, new equipment acceptance forms, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements. Execute plant validation studies in support of engineering, manufacturing, process development, facilities, quality control, and quality assurance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Generates, revises and executes documentation for validation studies ensuring compliance with QA and cGMP systems.Responsible for generating and executing validation protocols for equipment, instruments, utilities, and control systems through commissioning, URS, Software Acceptance Testing (SAT) IQ, OQ, and PQ phases.
- Responsible for temperature mapping of facility Controlled Temperature Units, Stability Chambers, Warehouse Space, Autoclave, Incubators, Humidity Controlled Rooms/Glove boxes and Cold Rooms. Involves the startup of new Controlled Temperature Units.
- Assist with contractor audits, supplier audits, pre-delivery inspections and on-site factory acceptance tests when related to validation. This may involve short periods of travel.
- Responsible for the calibration of equipment supporting validation protocols and ensuring the calibration specifications for the equipment are appropriate.
- Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment.
- Required to support the validation schedule within the scope of ongoing projects.
- Support facility qualification of classified environments.
- Support manufacturing, engineering, quality assurance, and quality control for validation related activities.
- Support the generation and execution of cleaning validation support activities, such as: sprayball coverage testing, equipment characterization reports, and equipment sampling SOPs.
- Assist with validation planning and risk assessments associated with validation activities.
- Resolve CAPA's, deviations, protocol incidents, and change controls related to validation protocols.
- Execute lyophilizer, HVAC, and autoclave annual requalification's and final package integrity testing.
- Generate data and reports for the validation system evaluation program.
Education and/or Experience
- University degree level or equivalent education/and or experience (complemented by a post-graduate and/or certification/license).
- 9+ years' practical experience, 5 years of which will be relevant experience required
- An accomplished leader and influencer, Agilent is where your expertise and solutions oriented approach will take you even further.
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.
- Ability to read, analyze and interpret common scientific and technical journals. Ability to communicate to a group of individuals through oral and/ or written materials.
- Knowledge of pharmaceutical manufacturing processes, quality improvements, and efficiency.
- Strong writing ability required.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.
- Ability to work effectively as a team to accomplish deadlines and objectives, yet make independent decisions on various tasks.Knowledge of cGMP guidelines as well as international regulations pertaining to the production of APIs and drug products.Knowledge of and ongoing technical competence and engagement in the field of Validation.
Agilent 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.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster available here:
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 contact +1-262-754-5030 (US and Canada only) or email email@example.com. EOE AA M/F/Vet/Disability