The Validation Coordinator will be responsible for overseeing all aspects of validation activities within Sentry’s state-of-the-art GMP facility, ensuring compliance with regulatory requirements and internal procedures. Responsibilities may include creating, reviewing, and executing validation protocols, such as Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ) and generation of validation/qualification reports. The position will also provide support and troubleshooting for all validated/qualified equipment as well as identify process improvements. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other applicable regulatory requirements.
Essential Duties & Responsibilities:
Work with Quality Assurance and other member of the Operations department to perform validation/qualification tasks, including but not limited to:
- Coordinate the execution of validation activities and ensure they are performed according to approved procedures and timelines.
- Review and approve validation documentation, including deviation reports, change controls, and validation reports.
- Provide guidance and support to cross-functional teams in identifying validation requirements and implementing appropriate validation strategies.
- Participate in risk assessments and recommend appropriate validation strategies to mitigate potential risks.
- Collect and analyze data from validation/qualification studies and prepare reports summarizing findings and recommendations.
- Conduct training for validation procedures, requirements, and best practices.
- Maintain current knowledge of industry trends, regulatory requirements, and new technologies related to validation activities.
- Develop, review, and implement approved validation/qualification protocols.
- Oversee testing and validation/qualification/calibration procedures to ensure compliance with regulatory requirements and industry standards.
- Ensure the Validation Team accurately and completely documents validation activities, including protocols, reports, and other relevant documents.
- Review trending data from storage environments, i.e. Monthly, Quarterly, etc., noting and investigating any irregularities.
- Create and track validation/qualification/calibration schedule and timelines to ensure the Validation Team meet deadlines.
- Periodically report on work progress and schedule status.
- Identify and execute both short and long-term strategic goals for the company involving technical, process, and equipment upgrades.
- Coordinate revalidation/requalification/calibration schedule with other operations including Preventative Maintenance and movement of materials.
- Oversee routine maintenance and calibration of testing equipment to ensure accuracy.
- Manage, schedule, and work with outside vendors for validation support as needed.
- Assist in response to alarms and take the appropriate actions to correct issues (i.e.: contact vendors, make repairs, transfer material physically and electronically, etc).
- Investigate process and quality problems regarding validated/qualified equipment, create, review, and implement approved corrective actions.
- Ensure the Validation Team is in compliance with all Standard Operating Procedures (SOP) for business needs.
- Identify, define, and propose project and process improvement opportunities.
- Follow biotech/pharmaceutical industry standards and applicable regulations in generating and updating required documentation.
- Assist other departments as needed.
- Additional duties as assigned by manager.
- May be required to travel to attend training or assist in validation activities at satellite locations.
- 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.
- Excellent leadership skills including the ability to lead projects with a broad scope/cross functional nature and an ability to impact outside departments while promoting teamwork between departments.
- Completes work in timely manner and drives results through team leadership. This would include working with the team/individuals to define specific goals and progress measuring tools/metrics.
- Ability to collect and analyze data, synthesize relatively complex or diverse information, and use intuition and experience to complement data.
- 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 apply concepts such as fractions, percentages, ratios, and proportions to practical situations. A strong statistical aptitude required.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Strong written and oral presentation skills and ability to present numerical data effectively.
- Ability to effectively present information to management and associates.
- Excellent communication skills with all levels of the organization and ability to develop rapport with other functional leaders within the company to make decisions.
- Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
- Demonstrates accuracy and thoroughness; Monitors own work to ensure quality.
- Follows instructions, responds to management direction; Commits to long hours of work when necessary to reach goals.
- Previous validation experience is required.
- Previous supervisor experience is preferred.
- Experience in a regulated industry required.
- Experience in the pharmaceutical and/or biotech industry or related field is a plus.
- High School Diploma or equivalent is required.
- A bachelors or associates degree, or an equivalent combination of education and experience, is preferred.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job including work, at times, inside cold storage chambers. The noise level in the work environment is usually moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Location: Indianapolis, IN
Department: Facilities Maintenance
Schedule: Full Time, On-Site
Experience: High School Diploma or equivalent, Validation (Required)
Travel Required: Some, Between Locations