- Develop and prepare process/cleaning validation protocols and related documentation according to established master plans and/or Standard Operating Procedures.
- Execute protocols as prescribed. Ensure all validation/qualification activities are properly completed and documented.
- Coordinate validation/qualification activities with other departments to ensure all aspects of the protocol are completed and reported as required. e.g. QC, QA, Production, etc. Prepare final validation/qualification summary reports for review and approval.
- Assist in training operators or other staff on validation protocols / standard operating procedures.
- Prepare, maintain, or review validation compliance documentation, including change management documentation.
- Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid and liquid dosage forms required for product transfers.
- Lead and/or participate in the implementation of new technologies, equipment and processes.
- Provide technical support and guidance for product transfer activities
- Provide planning and manage a variety of projects related to new business or changes to existing processes.
- Liaise with internal and external customers to meet project and company objectives.
- In conjunction with Program Managers, develop and/or update and maintain project timelines.
- Participate in the identification, investigation and correction of process-related problems.
- Ensure that validation/qualification activities are performed efficiently and are completed within the expected schedules and timelines.
- Prepare small scale batches (R&D, Pilot or Trial) required for product/method development, stability and process investigations.
- Initiate/revise appropriate Standard Operating Procedures related to validation/qualification activities as required.
- As directed by leadership and Quality Services, participate in focused communications with external regulators, auditors regarding the individual’s scope of expertise.
- Actively, participate in formal program gate reviews, both internally and with customer teams.
- Conduct audits of validation or performance qualification processes to make sure compliance with internal or regulatory requirements.
- Create, populate, or maintain databases for tracking validation activities and validated systems.
- Identify deviations from established product or process standards and provide recommendations for resolving deviations.
- Bachelor‘s Degree in Engineering, Chemistry, Pharmaceutical manufacturing, Pharmacy, or a related discipline. equivalent, with 5+ years of experience
- Demonstrated high level of knowledge, skill, or expertise in validation concepts, with experience using risk assessment tools.
- Proven organizational, time management, and project management skills (PMP designation or equivalent a preferred asset).
- Ability to analyze systems and processes and recommend process improvement.
- Excellent problem solving and troubleshooting abilities.
- Excellent oral and written communications, including technical report creation.
- Strong interpersonal skills.
- Demonstrated ability to work effectively as a team member with employees at all levels of the organization.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.