Job Details

Job Description:

Responsibilities:

• Performs validation document generation, program management, and protocol execution activities.
• Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
• Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
• Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
• Protocol execution and project activities.
• Execute qualification activities with oversight.
• Participate in department and site project teams.
• Perform qualification activities according to site objectives and timelines.
• Edit department SOPs and generate basic revisions as required.
• Execute CAPA plans, risk assessments, investigations, and root cause analysis.
• Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
• Performs general administrative and organizational activities.
• Management of time and work deliverables, regular interface and reporting to management.
• Complete regulatory, site, and department training requirements on a timely basis.
• Perform other tasks as assigned.

Education and Experience:

• Bachelor's degree preferred, preferably in Science or Engineering.
• 8 years relevant work experience required.
• n equivalent combination of education, experience and training may substitute.

Competencies: Knowledge, Skills, and Abilities:

• Working understanding of validation concepts and requirements.
• Intermediate written and verbal communication skills.
• Knowledge of cGMP.
• Critical reasoning and decision making skills.
• Knowledge of validation industry and regulatory requirements.
• bility to work independently and participate in a team.
• Work and time management skills.
• Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.

Working Conditions:

• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• The incumbent may be required to gown and operate in classified manufacturing environments.