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Validation Engineer II – Aiq
| Company | Takeda |
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| Location | Lexington, MA, USA |
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| Salary | $70000 – $110000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Mid Level |
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Requirements
- Minimum BS or BA. Engineering or Science; advanced degree would be ideal; and other job-related experience.
- 3+ years related experience in biopharmaceutical manufacturing environment validation, operations, engineering, or any combination thereof.
- Experience in Pharmaceuticals or Life Sciences industry would be ideal.
- Experience working in GxP laboratory or with analytical instruments would be ideal.
- Knowledge of computer systems and software validation would be ideal.
- Good communication and interpersonal skills. Able to clearly and concisely communicate with colleagues and stakeholders.
- Basic investigation techniques to determine true root cause and resolve protocol discrepancies.
- Familiarity with following tools and processes like TrackWise – CAPA, Deviation, Change Control, Veeva – Document Workflows, MS Office.
- Conducts work in compliance with cGMPs, safety, and regulatory requirements.
Responsibilities
- You will work with stakeholders to understand end user requirements and implement approved solutions.
- You will stay informed about technology trends in the market and evaluate for potential value to the company.
- You will execute and deliver tasks that are part of the Quality and Lab of the Future roadmap and existing QC portfolio.
- You will work with project teams (Lab Systems, QC, and QA) during project kick-off and planning to ensure appropriate tasks are accounted for as defined in local and global SOPs.
- You will create and update formal and informal department work instructions, tools, and job aids.
- Identify areas of improvement and propose solutions to senior staff.
- You will execute qualification of new and upgraded systems with oversight from senior staff.
- You will create lifecycle documentation including System Classifications, Qualification Plans, User Requirements Specifications (URS), Functional Risk Assessments (FRA), Installation and Operational Qualifications (IOQ), Trace Matrices, and Periodic Review Reports.
- You will partner with Quality Lab Systems personnel during qualification efforts to ensure optimum operational performance of delivered solutions.
- You will provide support during FDA/Regulatory Authority Inspections and Readiness.
- Participate in other QC activities as assigned on various initiatives and/or quality events.
- Determine qualification and testing approach in accordance with Takeda policies and procedures.
- Collaborate with cross-functional team members and subject matter experts to meet project objectives.
- Escalate roadblocks, project delays, and quality issues to project managers and senior staff for resolution.
- Advise internal QC system and process owners on adherence to Takeda policies and requirements. Consult and coordinate with internal application administrators or system owners to complete analytical instrument lifecycle deliverables. Coordinate with external vendors during setup, installation, maintenance, and troubleshooting of laboratory analytical instruments.
- Advise project managers on execution of analytical instrument lifecycle activities.
Preferred Qualifications
- Experience in Pharmaceuticals or Life Sciences industry would be ideal.
- Experience working in GxP laboratory or with analytical instruments would be ideal.
- Knowledge of computer systems and software validation would be ideal.
