Senior Validation Manager – Illinois
This position is responsible for the overall planning and execution of all validation/qualification activities for strategic site expansion projects. This includes budgeting, scheduling resources and executing activities to meet project deliverables from conceptual design phase through validation of new commercial operations. Works closely with site leaders, global stakeholders, and project teams to assure communication, implementation and management of lean commissioning, qualification and validation practices for equipment, facility, utility, cleaning, process, and computer systems. Interfaces with Manufacturing, Engineering, Utilities, QA, QC, and Regulatory agencies.
- Lead the planning and execution of a risk-based, science-based approach to qualification and validation activities in line with regulatory requirements.
- Supports the preparation of projects from inception through execution into a production state. Project documentation includes but not limited to conceptual ideas, costing options, project plans, Factory Acceptance and Site Acceptance testing, installation, commissioning protocols, qualification strategy/protocols, and project close out.
- Effectively schedules and communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to commissioning & qualification study execution/testing requirements and project status.
- Anticipates, recognizes and trouble shoots problems associated with commissioning and qualification studies, equipment, and procedures. Collaborates in resolution of technical problems or questions (quality problems, questions from authorities etc.) with other departments.
- Implements and utilizes project management tools necessary to assure proper resource loading and allocation to meet project timelines. Participates in the recruitment and selection of qualified personnel to support project deliverables.
- Prepares proposals and bid packages to secure contractor services. Tracks spending on approved contractor/project purchase orders. Ensure efficient usage of contractors who support qualification/validation activities.
- Contributes in the generation of regulatory filing packages, meetings with regulatory authorities and supports audits, as needed.
- Presents qualification/validation strategy to regulators and business partners and supports facility inspections /audits.
- Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
- Provide a positive and equitable working environment emphasizing the company Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Complies with requirements from company’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties/responsibilities assigned by senior management.
- BS, preferably in Engineering or a science field related to pharmaceutical manufacturing such as Microbiology, Biology, or Chemistry.
- Proven scientific and personnel leadership in Qualification and Validation in the Life Science / Pharmaceutical Industry with global business and regulatory exposure (at least 10 years in GMP environment, at least 5 years as a team leader and at least 2 years in qualification/validation).
- Knowledge of Microsoft Desktop Systems required.
- Proactive leadership skills.
- Familiar with team dynamics and Project Management. Must have proven organizational and interpersonal skills; coaching/mentoring skills to facilitate knowledge sharing. Problem solving abilities, creativity, efficient time management. Analytical and conceptual thinking. Efficient use of networking. Proven decision-making skills.
This global organization is one of the world’s leading pharmaceutical companies with a comprehensive line of therapies dedicated to the treatment of hemophilia, immune, wound-healing, and other coagulation disorders. They have experienced phenomenal growth over the past decade and are in the midst of a 10 year, $1B expansion, increasing capacity by 300% at the site! They offer a fantastic work culture dedicated to employee growth with a philosophy of “We know that when our employees grow individually and professionally, the company grows with them – and patients get the best care and attention they need.” Apply today!