Sr. Executive - Validation

Job Summary

This position requires independent evaluation, selection and application of standard engineering methods and practices, using judgment and ingenuity. Responsibilities include but are not limited to writing process validation plans, protocols, reports and being involved in the development and improvement of manufacturing processes. This position may be responsible for completing process requirements documentation, understanding the architecture and validation strategy for non-product software, writing, and executing test method validations, and maintaining the validation master plan. A thorough understanding of the process validation lifecycle is required for this position.

Essential Duties

• Serves as expert and main point of contact for Validation issues within area of responsibility.
• Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, product, process, and process utilities systems.
• Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ/PQ and final documentation in accordance with acceptable engineering practices.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Implements and understands FDA or regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Advises team members pro-actively on technical ideas and promotes skill development of teamwork.
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Understands FDA (CFR 820, 211, 210 and 21 CFR 11), ISO (13845 and 14971) and other regulatory requirements and validation guidance such as GHTF 2004 and FDA Process Validation Guidance 2011, ISPE GAMP5, PDA, ICH etc...
• Ensures compliance with Quality System and safe working practices.
• Plans, guides, and reviews projects and or work groups under one’s control to produce the desired outcome.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• MINIMUM QUALIFICATION REQUIREMENTS
  
  

Education

• Bachelor’s degree in engineering or B. Pharm is required
• Master’s degree in relevant field is preferred.
• Experience
  
  

Minimum 7 years working experience with at least 5 under a regulated environment.

Skills

• In-depth knowledge of U.S. and international medical device and drugs regulations and standards (21 CFR 820 & 210, 211, 11, EU MDR and ISO 13485).
• Requires demonstrated skills in technical innovation, technical leadership, polymer process or pharmaceutical.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge of relevant process control software applications.