Validation Engineer

Agilent Technologies•Boulder, CO

22h

About The Position

Responsible for the execution of all qualification/validation activities, excluding process validation, at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nucleic Acid Solutions Division. Generating and reviewing validation study documentation including validation plans, change controls, protocols, requirements specifications, asset induction requests, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements. Execute validation studies in support of engineering, manufacturing, process development, facilities, IT, quality control, and quality assurance. Manage or support the validation program. Suggests, develops and/or implements improvements to the program to ensure it maintains compliance with current regulatory and industry expectations. Supports validation deliverables related to Equipment, Instruments, Facilities, Utilities, Cleaning, Computerized Systems and ongoing validations, as needed. Generates, revises and executes validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 Annex 15, GAMP and other regulatory and industry standard requirements as deemed necessary. Supports Engineering (ENG), Facilities (FAC), Manufacturing (MFG), Process Development (PD), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) with validation activities. This includes management and support of validation planning and scheduling for overall project timelines and site objectives. Generates and revises documentation including, but not limited to, plans, risk assessments, traceability matrices, policies, procedures, equipment characterization reports, summary reports, specification documents and vendor qualification documents for validation studies ensuring compliance with QA and cGMP systems. Responsible for generating, executing, reviewing and approving validation protocols for equipment, instruments, utilities, and control systems through commissioning, URS, Software Acceptance Testing (SAT) IQ, OQ, PQ and cleaning phases. Responsible for the following ongoing validation efforts: Controlled Temperature Units (CTUs) Autoclaves Lyophilizers QC Glasswashers Periodic Review Periodic Monitoring Generate data and reports for the periodic review and/or periodic monitoring programs. Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment. Support facility qualification of classified environments. Responsible for assisting with spreadsheets validation activities. Support the generation and execution of cleaning validation support activities, such as: sprayball coverage testing, cycle development studies, equipment characterization reports, and equipment sampling SOPs. Manage, schedule, and/or support laboratory-based cleaning validation studies, including but not limited to method validations and surface recovery studies (i.e. worst-case soil studies). Support Manufacturing, Engineering, Quality Assurance (QA), and Quality Control (QC) to evaluate and resolve equipment cleaning issues and failures and to address any cleaning or cleaning validation related activities. Resolve CAPA’s, nonconformances, protocol incidents, and change controls related to validation. May serve as a validation subject matter expert for client and regulatory audits. May be responsible for attending client meetings as an engineering representative for purposes of addressing validation topics.

Requirements

Ability to read, analyze and interpret common scientific and technical journals.
Skill in communication, written and verbal.
Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding products and processes.
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.
Skill in managing various projects; 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 work effectively as a team to accomplish deadlines and objectives yet make independent decisions on various tasks.
Knowledge of pharmaceutical manufacturing processes, quality improvements, and efficiency as well as knowledge of governing FDA (e.g. 21 CFR 11, 210, 211 and ICH Q7) and international regulations pertaining to the production of APIs and drug products.
Experienced in working with validation programs, Nonconformance Investigations, Corrective Action/Preventive Action (CAPA) and Change Control.
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.
Knowledge of and ongoing technical competence and engagement in the field of Validation.
Bachelor’s degree (B.S.) or equivalent in engineering or life sciences field; and a minimum of 4 years (Advanced) validation related experience; or equivalent combination of education and experience.
Should possess a strong quality orientation, excellent communication skills, ability to work in a fast-paced team environment, high attention to detail and high ethical standards.

Responsibilities

execution of all qualification/validation activities, excluding process validation
generating and reviewing validation study documentation
executing validation studies in support of engineering, manufacturing, process development, facilities, IT, quality control, and quality assurance
managing or supporting the validation program
suggesting, developing and/or implementing improvements to the program
supporting validation deliverables related to Equipment, Instruments, Facilities, Utilities, Cleaning, Computerized Systems and ongoing validations
generating, revising and executing validation documentation for analytical instruments, process equipment and facility computer systems and software
supporting Engineering (ENG), Facilities (FAC), Manufacturing (MFG), Process Development (PD), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) with validation activities
managing and supporting validation planning and scheduling for overall project timelines and site objectives
generating and revising documentation including plans, risk assessments, traceability matrices, policies, procedures, equipment characterization reports, summary reports, specification documents and vendor qualification documents for validation studies
generating, executing, reviewing and approving validation protocols for equipment, instruments, utilities, and control systems through commissioning, URS, Software Acceptance Testing (SAT) IQ, OQ, PQ and cleaning phases
ongoing validation efforts: Controlled Temperature Units (CTUs) Autoclaves Lyophilizers QC Glasswashers Periodic Review Periodic Monitoring
generating data and reports for the periodic review and/or periodic monitoring programs
participating in both factory and site acceptance testing for new manufacturing and engineering equipment
supporting facility qualification of classified environments
assisting with spreadsheets validation activities
supporting the generation and execution of cleaning validation support activities
managing, scheduling, and/or supporting laboratory-based cleaning validation studies
supporting Manufacturing, Engineering, Quality Assurance (QA), and Quality Control (QC) to evaluate and resolve equipment cleaning issues and failures and to address any cleaning or cleaning validation related activities
resolving CAPA’s, nonconformances, protocol incidents, and change controls related to validation
serving as a validation subject matter expert for client and regulatory audits
attending client meetings as an engineering representative for purposes of addressing validation topics