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We are hiring a QA/Validation Engineer to support our Nucleic Acid Solutions Division (NASD) at our Boulder and/or Frederick, CO site. The primary focus for this role is Quality Assurance oversight of the validation program and activities at Agilent, specifically on computer system validation activities but may also include support of Equipment, Cleaning, and Process Validation activities as needed.
Responsible for reviewing validation documentation including but not limited to validation plans, protocols, final reports to ensure compliance with procedural and cGMP requirements. This position acts as a delegate for the Product Quality Manager and at all levels for other Quality Assurance (QA) Validation Engineers.
Duties and responsibilities:
- Leads quality oversight of validation activities with key emphasis on computer system validation and data integrity. Influences develop, and/or implements improvements to validation programs in partnership with impacted departments to ensure the program maintains compliance with current regulatory and industry expectations.
- Serves as computer system validation SME collaborating with and providing guidance, training, and/or direction from a quality perspective to other departments.
- Influences, revises, reviews, and/or approves documents including, but not limited to validation policies, SOPs, plans, risk assessments, protocols and reports.
- Performs Quality Assurance review and approval for other validation documentation, such as user requirement specification, commissioning documentation, protocols & reports, Quality Incident Reports (QIRs), and product/validation impact assessments relating to material, equipment, cleaning, computer or process changes.
- Leads or participates in risk assessments associated with validation activities.
- Collaborates with multi-functional teams (Information Technology, Engineering, Quality Control, Analytical Services, Manufacturing, and Process Development) to prioritize and schedule validation activities and ensure overall project timelines and site objectives are met.
- Supports other departments to evaluate and resolve validation issues and to address validation related activities.
- Generates, reviews and approves Nonconformance Investigations, Corrective Action / Preventive Actions (CAPAs) and Change Control records related to validation activities.
- Acts as a Quality Assurance Computer System Validation and Data Integrity SME during client and regulatory audits.
- Supports post-approval changes from a validation perspective to ensure the manufacturing process remains in a state of control.
Skills and experience needed to be successful in this role:
- Strong technical writing and communication skills (written and verbal).
- Excellent teamwork and problem-solving skills. Ability to collaborate with multi-functional teams to assess changes and nonconformances for impact to validation and to drive validation program improvements for compliance with regulatory requirements and guidance documents.
- Excellent time, priority and project management skills. Ability to use individual discretion in completing work assignments while assisting the group in establishing priorities, setting standards and working collaboratively to accomplish goals and objectives.
- Knowledge of GMP guidelines and international regulations pertaining to the production of APIs including, but not limited to, ICH, 21 CFR 210 and 211, 21 CFR Part 11, EudraLex and GAMP5.
- Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations. Ability to write reports, business correspondence, and procedures.
- Skill in using computers and software applications (MS Word, MS Excel, and Adobe Acrobat). Knowledge of statistical methods for use in data analysis a plus.
Temporarily a remote role due to COVID. Will be working from site after pandemic.