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RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
This individual will be responsible for the operations validation program and initiatives for the site. This role is a hands-on working manager position that will also manage and lead an Operations Validation team of 3 direct reports to meet the current regulations relating to process, environmental and cleaning qualifications. This person will interact with various departments within the organization to resolve validation issues and ensure proper qualification documentation is completed in a timely manner. This individual will serve as the operations validation SME for the site.
- Generate, review, approve, and execute process, facility, and cleaning validations.
- Create validation master plans in conjunction with QA.
- Ensure that all routine requalification and validation activities are carried out in accordance to the validation policy and site validation master plan and in line with documentation timelines.
- Review validation related documents for compliance to the validation requirements and good documentation practices.
- Participate in peer technical review of process and cleaning validation documents developed and executed by others.
- Provide coaching on process and cleaning validation topics.
- Lead groups in creation of requirements documents, risk assessments, process and cleaning validation.
- Provide technical support in resolving process and cleaning validation related deviations including executing and managing corrective actions.
- Manage, develop and coach the operations validation team individuals.
- Prioritize projects and manage assigned resources to meet organizational goals and objectives.
- Track and update schedules to provide upper management visibility of milestones and achievements.
- Ensure validation projects are adequately resourced by allocating internal and external validation resources as required.
- Oversee and manage validation contract resources including work prioritization, execution, and contractor budget.
- Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements.
- Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events.
- Work on multiple projects and initiatives simultaneously with shifting priorities.
- Represent the operations validation team in client audits and regulatory inspections.
- B.S. degree in engineering or scientific discipline
- 5 years validation experience in the pharmaceutical or medical device industry
- 2+ years of supervisory experience
- 10 years validation experience in the pharmaceutical or medical device industry
- Possess a strong knowledge of the principals of process and cleaning validation, current industry approaches, cGMP and the FDA validation guidelines.
- Must be proficient in developing process and cleaning validation protocols, master plans, project plans, studies, and procedures.
- Must have a thorough understanding the cleaning validation process including MAC studies, swab sampling techniques, worst case soil classifications, manual and automated cleaning procedure development, spray ball studies, cleaning recipes and cycles for COP/CIP systems, etc.
- Influence and coordinate activities of personnel over which he/she has no direct authority.
- Strong organizational skills
- Work independently with minimal supervision.
- Effectively communicate with all levels of the organization from the General Manager to the production operators
- Read and understand engineering and scientific documentation.
- Must be proficient with Microsoft Office and a CAD software package (Visio® or AutoCAD® preferred)
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