2020 is the year to make that change.....My firm has been retained by local pharmaceutical client as they continue to grow their company. In this newly created position of Validation Manager, you will be directly responsible for the creation of Validation Strategy; preparation and execution of Installation Qualifications, Operational Qualifications, Performance Qualifications, Process Validation and Cleaning Validation which are harmonized with corporate standards.
In this key role you will be responsible for the development and execution of the re-qualification plan for the site; and be required to contribute to the development of Site Validation Master Plans, cleaning validation master plans and computer validation master plans. You will implement and maintain computer systems in compliance with regulatory and company requirements and administer the Computer Validation Program.
Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required. Creates new validation approaches for new equipment; processes, or to align procedures and standards.
Administer and create the Computer Validation Program for the site, including the author/review/approval of Computer Validation Master Plans, Process Control Installation/Operational Qualification protocols, and alarm acceptance testing protocols, computer acceptance protocols and maintenance of computer systems in accordance with corporate and departmental procedures.
Provide key technical review with respect to SOP development and provide technical input for change control in order to assure that site needs are addressed, and compliance and industry standards are incorporated.
Review or revise Standard Operating Procedures (SOP’s) as required.
Responsible for developing the site re-qualification plan and strategy, execution and implementation.
Streamline testing requirements while maintaining regulatory and corporate compliance.
Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments, periodic reviews.
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
Participate on cross-functional teams, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient. Build and enhance interdepartmental relationships. Implement improvement initiatives with filling/packaging and facility/utility qualification activities.
As the site validation representative, present information or answer questions to regulatory agencies during the audit process regarding the validation program and specific validation studies.
Perform all job responsibilities in compliance with applicable EHS, GMP, and cfr21part 11 regulations, guidelines, policies, and standard operating procedures.
Manage and direct work of the (5) Quality Engineers.
Minimum of BS degree in science or engineering (chemical or life sciences/biotechnology) or related field.
Minimum of 5 years pharmaceutical experience in validation preferably with knowledge of secondary process equipment.
Prior experience interfacing with regulatory agencies, as well as exposure to the regulatory submission process.
Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
SME experience in any 3 of the following areas is required:
Packaging Equipment Qualification
Computer Systems Validation
HVAC, Smoke Studies and EM Qualification
Clean Utility Qualification
Experience in preparing validation master plans.
Familiarity with current Good Manufacturing Practices
Must be able to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
Must have demonstrated self-direct work habits and strong communication skills.
Must be a committed team player prepared to work in and embrace a team-based culture.
Familiarity with regulatory expectations regarding electronic records and electronic signatures.
Ability to work in a high complex matrix environment.
Sense of urgency, flexibility and accountability.
Ability to follow written procedures and document results in a neat and precise manner.
Intermediate computer skills required.
Stay current on developments in the field and company Standards.
Maintain attention to detail, while completing multiple or repetitive tasks.
Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Ideal candidates will have demonstrated experience in validation master planning for a site, with exposure to automation validation, and must have cGMP (pharma) along with cfr21 part 11. Newly created so build your team and create a transforming culture in mid-sized company.
Relocation offered to out of state candidates - please submit your resume to email@example.com