Lead Validation Engineer I/ II (Process/Cleaning)

Job Description

Lead Validation Engineer I/ II

Responsibilities:

• Subject matter expert in process and cleaning validation. An individual at this level is a technical expert in the field of validation.
• Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understanding
• Determine levels of importance or risk to be assigned to elements under review – using scientific rationale to justify scale of effort.
• Demand / extract appropriate definition of science underpinning element (product, process, equipment, cleaning regime) under review
• Link all efforts to the patient
• Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed equipment, process, equipment, facility or procedure
• Understand the science and areas of technical knowledge that underpin area of focus & must be able to apply this knowledge in the development of validation approach and in the presentation, documentation & review of outcome
• (As required) Move to other areas of activity applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery
• Represent the validation group (i.e. in certain forums position holder will be the sole representative of the Validation department, in such circumstances the validation individual should be prepared to answer for the whole group and/or where unable to do so immediately should take ownership for timely follow-up actions)
• Generate validation policies, guidance documents (SOPs, VMPs, VPPs) detailing best practice approach and implement these throughout the site
• Understand best industry practice, current developments and opportunities arising for the company
• Present to potential clients on why validation approach in the company’s provides both assurance of a safe pair of hands (compliance and adequacy of transferred process) and is effective (time & cost)
• Actively participate in Professional/Industry groups ~ to learn, to influence and to represent the company
• Much of the validation Department activity is concerned with maintenance of GMP compliance through monitoring, review, assessment and qualification of activities. The holder of the position will be required to contribute effectively in these areas. Contribution in areas such as change control, PPI’s, APR’s, and PR’s, VMP’s and SOP updates will be required as well as attendance in forums such as review boards and KPI reviews (see above with regard to representation)
• Ensure Validation systems (policies, procedures, reviews, VMPs, etc.) meet current / changing industry demands and that they do so effectively. The holder of this position is also responsible for the maintenance of these validation systems and ensuring compliance of Validation corrective actions.

Qualifications:

• Must be familiar with Regulatory requirements and guidance applicable in area(s) of deployment.
• Must be familiar with the relevant areas of science (some indicated in table below) applicable in area(s) of deployment.
• Must be familiar with the general areas of Technical knowledge / understanding indicated in table below.
• Experience with sterile processes a strong plus.
• Experience with JMP or other statistical software and knowledge of statistical analysis is a strong plus.
• Experience with Valgenesis, Veeva, and Trackwise is a plus.
• Lead Validation Engineer I
• Minimum 5 years validation experience in the pharmaceutical industry
• Experience with sterile processes is a strong plus
• Lead Validation Engineer II
• Minimum 8 years validation experience in the pharmaceutical industry
• Strong statistical knowledge, including analysis of process capability and control charts
• Experience with sterile processes is required
• Familiarity with cleaning validation maximum allowable carry-over limit calculations and rationale.

• Ability to objectively review.
• Ability to make judgements in the wider context of quality/compliance
• Ability to perform effective trouble shooting
• Ability to command technical authority on specific projects