Validation Engineer

About the role

Agilent's Advanced Therapeutics Division is a contract development and manufacturing organization providing products and services for our clients that provide medicines for many indications improving health for patients. This position supports commissioning Qualification and Validation (CQV) activities (excluding process validation) at our facilities in Colorado in a dynamic, fast paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics. This position is focused on the field of cleaning validation, specifically supporting laboratory studies including method verification, cleanability studies, and surface recovery to aid in MACO and ARL calculations.

Responsibilities

• Generate and review 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
• Support validation deliverables related to Equipment, Instruments, Facilities, Utilities, Cleaning, Computerized Systems and ongoing validations, as needed
• Generate, revise and execute 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
• Support Engineering (ENG), Facilities (FAC), Manufacturing (MFG), Process Development (PD), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) with validation activities, including management and support of validation planning and scheduling for overall project timelines and site objectives
• Generate and revise 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
• Generate, execute, review and approve validation protocols for equipment, instruments, utilities, and control systems through commissioning, URS, Software Acceptance Testing (SAT), IQ, OQ, PQ and cleaning phases
• Support ongoing validation efforts of systems including Controlled Temperature Units (CTUs), Autoclaves, Lyophilizers, QC Glasswashers, and Periodic Review
• Generate data and reports for the periodic review and/or periodic monitoring programs
• Participate in both factory and site acceptance testing for new manufacturing and engineering equipment
• Support facility qualification of classified environments
• Assist 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

Qualifications

• Bachelor's Degree (B.S.) or equivalent in engineering or life sciences field
• 1+ years relevant experience
• 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
• Skill in managing various projects; must be able to use individual discretion in completing work assignments; ability to work effectively as a team while making independent decisions on various tasks
• 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

Pay

The full-time equivalent pay range for this position is $82,480.00 - $128,875.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.