Sr Engineer, Validation

Sr Engineer, Validation

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary

The Sr. Engineer, Validation ensures cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures. This position supports ensuring accountability and oversight within the validation program, validation projects, and leads innovation. Sr Engineer, Validation will independently work on multi-faceted projects (Capital, Client and Overhead), manage multiple tasks/priorities. Core competencies for this position are Collaborates, Communicates Effectively, Directs Work, Ensures Accountability and Customer Focus.

This position provides Subject Matter Expertise (SME) and oversight in multiple disciplines owned by the validation department. These disciplines are;
Commissioning and Qualification, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation. The Sr. Engineer, Validation performs with a high degree of autonomy and represents the department on interdisciplinary teams. This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively, collaborates and bridges GAPs. The Sr. Engineer, Validation supports engineering, quality, manufacturing sciences and technology, and manufacturing by providing SME support and accountability within the Validation department.

The Sr. Engineer, Validation will also be responsible for providing leadership and technical guidance to the team aimed at implementing best practices and improving the overall performance of the team.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Technical Expertise Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identification and resolution of non-conformances consistent with site procedures and practices. Provide equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases. Reviews and approve technical documentation including system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols).

Perform equipment, aseptic processing, steam sterilization and process validation and their associated control systems. Review and approve department deliverables (protocols and quality systems) Perform investigations and implement corrective actions related to CAPAs and deviations. Developing broader skills personally by applying this knowledge to work assignments and departmentally through resource and program development. Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies.

Participate in regulatory inspection and response activities. Represents validation on internal teams, committees and at technical conferences. Report status and progress of qualification activities or projects to the Leadership team. Leadership Skills Owns assigned Validation Plans, Procedures and Projects supporting program compliance. Manage and directs work for assigned projects ensuring activities are on time, within budget, meet GxP and company requirements.

Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs. Demonstrated success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing. Provide customer focus supporting engineering, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert within the Validation department. Problem Solving Proposes unique solutions to complex problems using technical proficiency, creativity and collaboration with others through…