WHAT WE ARE LOOKING FORLead the Validation Team to provide excellent service to customers and ensure compliance to cGMP FDA/EMEA regulations. Serve as a Validation subject matter expert, track, and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing, and cleaning processes.
Support ongoing site wide projects by collaborating with experienced members of the Engineering, MS&T, Operations and QA teams to identify roadblocks and additional efficiencies. Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting/reviewing/approving protocols, and reports, evaluating deviations/change controls and initiating revisions of GMP documentation related to validation.
YOUR ROLEEssential Functions- Responsible for the day-to-day activities conducted by the Validation department.
- Provide leadership on the activities of the internal validation staff as well as external validation contractors.
- Lead team member assignments to assure tasks are completed accurately and to schedule.
- Establish priorities to ensure that deadlines are met, and budgets are not exceeded.
- Oversee the site Validation Master Plan, using input from internal and external resources for continuous improvement.
- Create, coordinate, maintain and enforce Validation systems, policies, and procedures.
- Participate in audits and inspections conducted by internal and external entities.
- Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes
- Review and approve all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.
- Ensure all revalidation requirements are met for equipment, process, and cleaning site wide.
- Manage the revalidation program.
- Team member for new product introductions, regulatory compliance initiatives, implementation of process improvements.
- Forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex.
- Write and review policies or procedures for compliance with regulatory guidance.
- Active leader and decision maker, as needed, on internal projects related to formulation, filling, environmental, facility improvements and developing new approach to business.
- Work with Regulatory Affairs to prepare Regulatory Submission Documents for project initiatives.
- Lead initiatives to streamline processes and workflow by initiating Operational Excellence initiatives.
- Interact with management, senior management, and stakeholders to determine project scopes, timelines, and prioritization of global and local projects.
- Manage validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan.
- Direct supervision of contractors or other specialists.
Key Requirements- Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities, classified facilities, cleaning, and Process Validations.
- Thorough knowledge of the of steam sterilization, cleaning and process validation and equipment qualification.
- Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment.
- Perform administrative duties associated with managing a department and staff. (i.e. establish group goals, and performance reviews).
- Strong coaching and mentoring skills and a track record of developing direct reports.
- Identify quality issues, and in conjunction with site Quality Manager, recommend and implement corrective and preventative actions.
- Good communication with multiple individuals, departments, contractors, auditors and strong organizational skills.
- Knowledge of cGMP, cGLP, cGXP, FDA, ICH, EMEA and 21 CFR 11 regulations, guidelines, policies and procedures for parenteral/injectable products.
- Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
- Knowledge of agency and vendor audits.
- Able to respond/react with appropriate urgency/ professionalism and make decision under pressure.
- Support goals and initiatives tied to Guerbet Plan and department goals.
- Evaluate current systems and process to determine upgrades, additional technology and improve as needed.
Department Specific/ Non-Essential Functions:- Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility. Perform incident investigations and follow through regarding corrective actions.
- Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
- Other duties as assigned with or without accommodation.
YOUR BACKGROUNDPreferred Skills/ Qualifications: - Knowledge and application of Risk Based approaches to Validation.
- Able to balance, resources, voice of the customer and timelines, while implementing robust and defendable validation strategies.
- Ability to work independently in a fast-paced environment and manage multiple project and priorities.
- Candidate should possess experience in equipment C&Q, cleaning, sterilization, and process validation.
- Demonstrated expertise in Six Sigma and Lean projects that utilized the concepts and tools for problem definition, root cause analysis, risk assessment, process development, and statistical analysis.
- Strong knowledge of ICH guidelines and QBD principles applicable to a manufacturing environment, with successful application experience.
- Industry guideline knowledge of 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, IPSE, PDA, MHRA, PICs, MFDS.
- Validation experience, verbal and written communications, ability to manage multiple tasks.
- Strong team member with demonstrated ability to work collaboratively with others.
- Candidate must possess personal drive and the ability to schedule work assignments so that they are concluded in a timely, complete, and error-free manner with the highest level of accountability.
- Proficient and effective communication with both team members and other plant support groups.
- Planning, organization, leadership, teamwork.
Education and Experience: - BS degree in engineering/ life sciences.
- 10 years of validation experience in a pharmaceutical environment.
- 8 years supervisory experience.
- Relevant experience with industry process validation requirements and expectations.
- Working knowledge of the science and technology for the major unit operations associated with parenteral/ injectable manufacturing/ packaging operations.
- Experience with troubleshooting/ problem-solving and risk assessment/ mitigation
