Quality Assurance - Validation Engineer

Job Description

The QA/Validation Engineer is responsible for Quality Assurance oversight of the validation program and activities at Agilent Technologies Nucleic Acid Solutions Division (NASD).  The position supports Computer, Equipment, Cleaning, and Process Validation activities as needed.

Responsible for reviewing validation documentation including but not limited to validation plans, protocols, final reports and associated risk assessments and characterization studies to ensure compliance with procedural and cGMP requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide Quality oversight of validation programs.  Influences, develops, and/or implements improvements to validation programs in partnership with impacted departments to ensure the program maintains compliance with current regulatory and industry expectations.

• Partner with Engineering Validation to define, implement, and improve Validation Policies and SOPs.

• Provide the Quality Assurance (QA) review and approval for validation documentation, including but not limited to user requirement specifications;

• commissioning documentation; validation protocols and reports; change control documentation; process monitoring/review reports; automated systems method reviews.

• Participate in risk assessments associated with process design and validation activities.

• Collaborate with cross-functional teams to ensure overall project timelines and site validation objectives are met. Partner with Engineering, Manufacturing, Information Technology (IT), Technical Services, Facilities, Process Development and others as needed to prioritize and schedule validation activities.

• Provide Validation guidance, training, and/or direction to other departments with respect to regulatory requirements as well as Agilent policies and SOPs.

• Assist other departments in evaluating and resolving challenges and discrepancies encountered during validation.

• Review and Approve Nonconformance Investigations, Corrective Action / Preventive Actions (CAPAs) and Change Controls related to validation activities.

• Together with other area experts, act as a validation subject matter expert for client and regulatory audits.

• Ensure that changes to the facility, utilities, equipment, cleaning, and computerized systems are thoroughly evaluated to determine the necessity of additional validation activities post-implementation.

KNOWLEDGE, SKILLS, AND ABILITIES:

To perform this job successfully, an 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.

• Familiarity with GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH, 21 CFR 210 and 211, 21 CFR Part 11, the FDA guidance on Process Validation, the EMA guidance on Process Validation, the Global Harmonization Task Force on Process Validation, EudraLex and GAMP 5.

• Skill in written and verbal communications.  Ability to efficiently respond to inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding products and processes.

• Excellent teamwork and problem-solving skills. Ability to collaborate with cross functional teams to assess changes and nonconformances for impact to validation and to drive validation program improvements.

• Knowledge of and skill in using computer software and hardware applications.  Must be proficient with MS Word, MS Excel, and the use of computerized statistical tools.

• Skill in time, priority, and project management. Must be able to use individual discretion in completing work assignments while assisting the group in establishing priorities, setting standards and working collaboratively to accomplish deadlines and objectives.

• Ability to read, analyze, and interpret industry related periodicals, SOPs, and government regulations.  Ability to write reports, business correspondence, and procedures.

• Familiarity supporting and/or performing validation activities (equipment, cleaning, utility, computer, process, etc.), nonconformance investigations, CAPA, and change control programs.

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