Manufacturing Engineer

Job Description

Manufacturing Validation Engineer is responsible for the execution/review of cleaning validation activities at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nucleic Acid Solutions Division. Generating and executing validation study documentation including protocols, cycle development protocols, documentation of new product introduction information for new and existing clients, execution of laboratory studies to support the cleaning validation program for new product introduction oligonucleotides. Laboratory studies, final reports, deviations, and SOPs while ensuring compliance with cGMP requirements.

• Designs and develops cleaning procedures for new products and manufacturing equipment.

• Provide technical support to cleaning activities associated with the manufacturing process.

• Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.

• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures.

• Works cross-functionally to ensure adherence to cleaning program documentation and site initiatives.

• Provides cleaning laboratory program executed studies for presentation in client and regulatory audits.

• Develops technical and manufacturing documents necessary for development studies, cleaning validation, and post-validation process verification, in alignment with corporate and industry standards.

• Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root cause.

• Maintains alignment with internal technical personnel regarding validation practices for products, processes and equipment.

• Partners with cross- functional areas on validation laboratory study implementation.

• Assists with risk assessments associated with laboratory cleaning validation studies activities.

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

• Ability to be self-led when laboratory job tasks are assigned for laboratory testing with QC analytical instrumentation is required.

• Ability to have a QC laboratory analyst experience.

• Ability to understand Laboratory analyst techniques and lab studies execution.

Qualifications

• Bachelor degree or equivalent education/and or practical experience.

• 2+ years' experience in cleaning validation and analytical testing (UV, TOC, degradation, HPLC, MPLC).

• Experience executing cleaning validation and QC analysis for the required data.

• Knowledge of pharmaceutical manufacturing processes, quality improvements, and efficiency.

• Strong writing ability required.

• 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 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 Cleaning Validation and Quality Control Analysis.

#LI-TH1

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.

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 job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Pay Range

$76,080.00-$118,875.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

No

Benefits in Brief

Travel Required

Occasional

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Manufacturing