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at TOLMAR Inc.
Purpose and Scope
Working in a team environment, the Validation Manager has overall responsibility for management and, where appropriate, execution of process, cleaning, facilities, aseptic, fill/packaging and automation validation for all local manufacturing sites. The manager assures that validation activities associated with remediation, technology transfers, and product launches are delivered on time and in compliance with Tolmar policies and procedures and per the guidance and requirements of the CFR, ISO and international regulations.
Essential Duties & Responsibilities
- Provide leadership in a fast-paced production environment with high quality and regulatory standards; supervise the Validation Specialists and Validation Engineers.
- Provide direction, mentoring, coaching and development towards personal growth, enhanced job performance and career satisfaction.
- Create, write and update validation guidelines, policies and procedures.
- Develop and update the Validation Master Plan for the manufacturing sites (Cornerstone, Centre and Duff) on an as-needed basis.
- Work with the production, engineering, maintenance, and development departments to assure that all required prerequisite documentation is appropriately developed to support process, cleaning, facilities, aseptic, filling/packaging and computer validation activities.
- Track and provide technical direction to validations of aseptic and semi-solid manufacturing to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements.
- Review product transfer protocols and reports and design/develop a validation strategy.
- Provide validation support to Dermatology and Aseptic manufacturing, assess impact to product quality and determine appropriate actions.
- Create, write and execute required validation protocols and reports.
- Coordinate validations for equipment and/or processes with outside vendors.
- Participate in audits and follow up on corrective actions.
- Conduct and participate in investigative meetings relating to validation manufacturing test failures. Assess impact of production deviations.
- Review and approve all validation test protocols and final reports.
- Maintain up-to-date knowledge of cGMP regulatory issues, particularly pertaining to validation, and ensure that company validation policies and procedures are updated accordingly.
- Contribute to the development of departmental budget and monitor expenditures.
- Select, develop and evaluate Validations employees to ensure functional objectives are met.
- Manage the validation systems periodic review and change control activities.
- Responsible for working closely with cross functional teams to ensure compliance and maintaining systems in a validated state.
- Coordinate activities with different cross functional team members and execute projects in a timely manner.
- Perform other related duties as assigned.
Knowledge, Skills & Abilities
- Must possess a solid understanding of FDA validation guidelines and industry best practice for this field and be able to implement validation standards on a daily basis.
- Ability to work independently with minimal supervision.
- Organized and able to meet project deadlines.
- Proficient knowledge of cGMPs, ISO, EU, and JP standards for aseptic processing, clean rooms and semi-solids manufacturing.
- Proven ability to create/change procedures or documents.
- Excellent oral and written communication skills demonstrated through interactions internally and externally.
- Ability to work well with employees at all levels.
- Computer literacy in Microsoft Office programs, including Outlook, Word, Access, and Excel.
- Proficient knowledge and understanding of validation requirements.
- Knowledge and understanding of aseptic and semisolids operations requirements.
- Effective organization and project management skills.
- Effective troubleshooting and problem solving skills.
- Proven skills in managing major Validation projects.
- A valid driver’s license and acceptable motor vehicle record may be required.
The Validation Manager is expected to operate within the framework of Tolmar’s Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
- Bachelor’s Degree in scientific or engineering discipline required.
- 10 or more years of experience in the pharmaceutical or medical device industry in quality assurance or validation.
- 5 or more years of experience performing validation activities in an aseptic environment.
- Previous experience in a supervisory position required.
- Working conditions include general office environment conditions, as well as in manufacturing areas.
- General hours are Monday through Friday, with some overtime and weekend work as needed.