Rochester, NY Posted: 5/19/2021
This position is responsible for leading our validation team to meet the needs of customers, regulators, projects and commercial production. This position is responsible for ensuring that the validation activities are performed within an appropriate level of cGMP, HS&E and DEA compliance. Ensure that the Validation group delivers on implementation of Continuous Process Verification, Serialization and Aggregation of current and future products.
ESSENTIAL DUTIES / RESPONSIBILITIES:
Validation Guidance Producing Executed Protocols that Ensure Qualified Systems & Equipment
- Team develops and executes equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities supporting these operations.
- Ensures appropriate validation activities are included in site or team project plans: including tasks, manpower requirements, and duration.
- Analyzes data, utilizing appropriate statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
- Investigates and assists in resolving deviations/ exceptions from the predefined acceptance criteria.
- Draws conclusions from data, observations, deviation/exception and investigation as to whether a process is considered valid.
- Interacts with and coordinates compliance efforts with other departments including, but not limited to: Operations, Engineering, QA, QC, and development functions to provide a high degree of assurance that all qualification/validation activities are completed to requirements.
- Ensures that validation team writes validation protocols (commissioning/ qualification, PQ, and Controls) for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.
- Writes summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/ qualification procedures and policies.
- Maintains protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
- Ensures protocols, verifications, validation plans and summary reports are maintained according to requirements.
Skills & Performance of People Are Appropriate for Business Needs
- Ensures self and staff understand the organization’s vision, values, goals and strategies and their relationship to their daily work.
- Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.
- Helps others to successfully manage organizational change. Facilitates the implementation and acceptance of change within the workplace. Acts as a champion for change. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.
- Understands HR policies and practices and uses them to manage employees.
- Ensures money, technology, and staff are allocated to achieve optimal results.
- Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles. Uses this information to drive improvements and/or prepare for changing requirements.
- Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.
- Ensures that the Validation group delivers on implementation of Continuous Process Verification, Serialization and Aggregation of current and future products.
- Bachelor’s Degree required.
- Master’s Degree/ Ph.D. preferred
- 12 years’ experience in a role of similar scope and complexity. Experience may be combined across engineering, quality assurance, and validation.
- Minimum 5 years process validation or equipment qualification experience.
- Previous supervisory experience is highly preferred
- Stay abreast of changes in cGMP trends for validation and industry standards.
- Effectively communicate, both written and oral, validation requirements and policies to a diverse group of technical personnel.
- Ability to manage multiple projects in different phases of project completion, at varying times.
- Motivate and challenge internal and external personnel to maintain a high level of customer service and system compliance.
- Ability to effectively change and adapt project scope creep and change in timelines.
- Understanding of FDA requirements for validation.
- Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation).
- Demonstrated ability to deal effectively across multiple functional departments in a matrixed product team structure.
- Demonstrated success in building and running strong, high-performing teams.
- Presentation abilities to technical and management teams
- The ability to read, write and communicate in English.
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