Wave Life Sciences USA seeks a highly motivated Senior Validation Engineer to join its team in Lexington, Massachusetts. This position will report to the Associate Director, Validation.
This is an ideal growth position for an individual who is interested in learning cutting edge technologies and who thrives in a team-oriented, fast-paced, and cross-disciplinary biotech environment. The candidate will be responsible for validation support of clinical and GMP manufacturing systems, equipment, and utilities, computerized systems, shipping qualification, and ongoing validation maintenance, with the goal of advancing Wave Life Sciences therapeutic programs and discoveries. The candidate must be able to quickly build and nurture project teams, and work in highly professional, knowledgeable, and collaborative manner. Prior experience and demonstrated leadership capabilities in validation is required.
Technical duties include developing and executing validation testing, while adhering to GMP regulations, and identifying and advancing continuous improvements into validation policies and procedures. Leadership duties include assisting with developing validation strategies, leading through change, coaching, and motivating others.
Lead complex validation projects and related work, and serve as program SME
Ability to build and manage project teams, and work in a highly professional, knowledgeable, and cooperative manner with other contractors and personnel.
Develop, execute, and report validation projects in the following disciplines: Facilities, Equipment, Utilities, Controlled Temperature Units, Computer Systems, Shipping/Cold Chain, Validation Maintenance
Participate and contribute to the design and development of GMP manufacturing equipment validation and validation strategy.
Develop and assess the following Quality System elements for Validation: CAPAs, Change Controls, Non-conformances
Manage protocol and final report development, execution, and approval to provide documented qualification / validation of cGMP utilities, facilities, computer systems, and equipment
Support and develop validation policies, SOPs, risk assessments, validation project plans and validation master plans.
Provide technical assistance and handles any questions or concerns from regulatory agency representatives in reference to validation, including direct interaction with regulatory authorities, internal auditors and third-party auditors.
Support the commissioning, qualification and validation needs of all internal and external customers
Provide regular updates to management
Demonstrate an aptitude for hands-on creative problem solving
Capacity to be highly productive in a fluid and fast-paced work environment
Committed and collaborative team player
Education and Experience:
BS degree in engineering related technical discipline, with a minimum of 8 years pharmaceutical or biotechnology industry experience. An advanced degree or industry certifications are given additional consideration.
Significant knowledge of company internal policies, Regulatory (EMA, FDA) requirements, and industry guidance (ISPE, PDA)
Must be able to function in a timeline-driven dynamic environment, be able to follow SOPs, and rapidly adapt to new techniques and protocols.
Skills / Pre-requisites:
Must be capable of multi-tasking and performing assignments that have loosely defined objectives
Ability to effectively communicate verbally and in writing
Ability to apply working knowledge of regulatory requirements and other related disciplines.
Must be able to plan, coordinate, perform, and supervise direct reports / contract staff with minimal oversight
Must be capable of working in a multidisciplinary cross-functional team
Must be capable of troubleshooting technical issues related to commissioning, qualification and validation efforts including but not limited to issues with execution, equipment failure, strategy changes or personnel errors
Must be able to negotiate when necessary and compromise with other project team representatives to collaboratively achieve project goals
Should be able to climb a ladder, reach, bend, and lift loads up to 40 lbs.
Incumbent will be required to carry a cellular phone and be available to support manufacturing operations, as required.
Must possess valid driver's license. Travel between Wave Life Sciences sites may be required.
Wave Life Sciences