Job Details:
The Supervisor, Validation and Calibration will be responsible for overseeing and implementing validation activities to ensure compliance with current regulatory requirements and industry standards. This position leads, directs, and coordinates validation activities in accordance with the Company’s procedures, policies, goals, and objectives. As the company expands, the Supervisor will establish and guide a team of validation professionals to address the current and future requirements of the Company and its Clients. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other applicable regulatory requirements.
Essential Duties & Responsibilities:
The primary function of the Validation department is to create, monitor, and maintain the validation and calibration processes of Sentry’s storage environments. The Supervisor oversees the department and is responsible for its operational performance, including the execution and compliance of validation related processes, while proactively planning to ensure the appropriate availability and allocation of resources. Specific responsibilities include but are not limited to:
- Regularly review validation and calibration related SOPs and drive their development and revision.
- Draft and provide investigation assistance of validation or calibration related deviations and CAPA planning.
- Assist Quality Assurance and other departments in performing risk assessments for any changes to validated environments or related systems.
- Develop and implement validation protocols for temperature-controlled storage environments compliant with regulatory requirements and industry best practices.
- Oversee the execution of validation studies, including protocol development, execution, data analysis, and final reporting.
- Review validation documentation, including protocols, deviations and change controls to ensure accuracy and compliance with established procedures.
- Collaborate with Quality Assurance to develop new test strategies when appropriate to ensure validations are thorough and compliant with regulatory requirements.
- Provide support to validation team members during validation and calibration activities.
- Coordinate with cross-functional teams to define validation requirements and timelines for projects and ensure alignment with business objectives.
- Responsible for overseeing area/site Validation initiatives/projects and personnel ensuring adherence to timelines and deliverables.
- Ensure robust and timely stakeholder communication regarding critical validation/calibration issues.
- Provide training and guidance to validation team members on procedures and regulatory requirements.
- Assist with tracking of validation team expenses for budgetary planning.
- Aid in development and maintaining a training plan for onboarding of new validation employees.
- Participate with Validation functions in regard to human resources including interviewing and selection, organizational development, and mentoring, coaching, and counseling.
- Develop specific, measurable, achievable, relevant, and time bound KPIs and metrics for validation team.
- Periodic travel to satellite locations may be required to provide operational assistance and oversight.
- Other duties and responsibilities as assigned.
Competencies:
- Excellent leadership skills including the ability to lead projects with a broad scope, cross functional nature, and ability to impact outside department while promoting teamwork between departments.
- Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
- Excellent communication skills with all levels of the organization and ability to develop rapport with other functional leaders within the company to make decisions.
- Drives results through team leadership. This would include working with the team/individual to define specific goals and progress measuring tools.
- Strong problem solving, solutions orientation and presentation skills.
- Able to prioritize and plans work activities; set goals and objectives; organize, schedule, and coordinate activities with other people and availability of needed equipment; use time efficiently.
- Ability to sort out and organize multiple projects, documents, or other fragmentary information, manage competing demands.
- Ability to read, analyze and interpret technical reports and facility drawings. Ability to respond to common inquiries from clients or service vendors, or regulatory agencies.
- Ability to translate complex technical concepts into clear, understandable language.
Education and/or experience
- Previous validation experience is required; minimum 5 years.
- Previous supervisor experience is preferred.
- Experience in a regulated industry required.
- Experience in the pharmaceutical and/or biotech industry or related field is required.
- High School diploma is required.
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Location: Indianapolis, IN
Department: Facilities Maintenance
Schedule: Full Time, On-Site
Education: High School Diploma (Required)
Experience: 5 Years Validation (Required)
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