Are you looking to join a company that has an outstanding history of developing and producing biodefense and lifesaving drugs and has signed deals with some of the largest drug development companies to manufacture the next COVID vaccine?

Are you looking for a job with a mission-oriented biotech where you can have a real impact at work and in the world?

A company where you feel a sense of ownership in your future, where you feel like you advancing in your career? If so, look no further.

Our client is seeking a Sr. Engineer of Process Validation within the Manufacturing Sciences and Technology department to be responsible for leading defined Process Validation efforts and overall PV strategy and execution, as well as contributing and leading Technology Transfer activities where needed. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals on manufacturing process and validation, which includes biopharmaceutical best practices, statistical analysis, regulatory requirements for validation, among others.

This role includes cross-functional collaboration and partnership with MS&T leadership, Manufacturing, Quality, and customers to develop and execute the PV strategy.

Essential Functions:

• Engage with MS&T Leadership Team to ensure appropriate alignment of resources to support site projects and routine operational needs

• Maintain good working relationships with internal and external partners/customers

• Responsible for working with applicable Project Managers to ensure departmental resources are appropriately allocated based on work scope and technical needs.

• Track and report status on progress against plan and ensure commitment to key stakeholders are met in a timely and high-quality manner

• Apply scientific rationale and validation expertise to execute on process validation strategies to support scientifically sound and robust regulatory applications

• Lead execution of Continued Process Verification strategy with MS&T team

• Lead Validation Activities including hold studies, filtration, and extractable/leachable studies

• Lead technology transfer and continuous improvement activities across ongoing and incoming projects

• Author technology transfer, validation, and manufacturing documentation including plans and reports

• Provide technical support to manufacturing in production suite as needed

• Assist with implementation of unit operations in the manufacturing suite

• Determine equipment needs and CapEx for projects

• Support Process Validation during FDA and other regulatory agency inspections, develop CMC sections of regulatory applications, with leadership oversight

• Support initiatives ensuring department and site Validation Compliance including training, communication forums, continuous improvement

• Lead change in a positive manner through the department

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Minimum Education, Experience, Skills:

• Degree (Bachelor to Ph.D.) in a related field with a minimum of 8 years industry experience including manufacturing in a regulated environment under cGMPs

• Experience in managing scientists/engineers in a fast-paced, challenging environment. It is essential that this leader creates an engaging workplace with a strong focus on strategy and developing and empowering people

• Proven track record of management and leadership effectiveness

• Strong knowledge of ICH guidelines and QbD principles applicable to a manufacturing environment, with successful application experience

• Diverse and demonstrated technical knowledge with a strong risk management mindset

• Strong technical and communication skills: oral/written and listening. Must have good verbal skills - the ability to communicate clearly and extemporaneously to a variety of audience types.

• Must have good written communication skills - the ability to tailor communications to all levels in the department and prepare appropriate updates to senior management. Must have effective communication skills for “upward” and “downward” audiences.

• Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability

• Computer skills (MS Office, JMP/MiniTab or equivalent statistical software, Visio, MS Project)