Senior Specialist, Technical Quality

RESILIENCE (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com.

Position Summary & Role:

The Sr. Specialist, Technical Quality will focus on the quality engineering aspects of biopharmaceutical manufacturing, to include validation, change control and risk assessment. This is an exciting, hands-on opportunity to oversee commissioning and qualification programs for the start-up of a new manufacturing facility. The Sr. Specialist, Technical Quality position reports to the Site Quality Head.

The position will be located in East Norriton, PA.

Job Responsibilities:

• Review and ensure compliance of validation lifecycle documents and equipment acceptance tests

• Provide quality oversight during qualification of critical manufacturing equipment and utilities (e.g. gas systems, HVAC, Biosafety Cabinets, incubators, freezers, etc)

• Participate in risk assessments to identify and mitigate equipment and system failure modes

• Provide technical quality input to new facility design changes as new business needs emerge

• Facilitate and approve change controls related to equipment, facility, and utilities

• Review and approve plans and SOPs to support validated facility and equipment status

• Provide oversight of preventive maintenance and calibration work orders and overall system health

• Participation in communities of practice related to qualification and validation, as needed

• Drive improvement of key performance metrics for the validation and change control systems

• Provide technical presentations to senior management and external stakeholders, as needed

Preferred Experience, Education & Qualifications:

• Bachelor’s degree of higher in Life Sciences, Chemistry, Biology, Engineering or related field

• Minimum of 5 years of relevant biotechnology or engineering experience

• Hands-on experience with oversight of operational functions

• Knowledge of global GMP regulatory requirements for qualification and validation

• Ability to travel in the US and internationally, as needed, for critical FAT oversight

Other Ideal Personal Characteristics:

• Ability to simplify and synthesize difficult concepts and present to audiences at all levels

• Proven track record of being able to learn complex equipment and systems quickly

• Experience with facilitating and organizing challenging technical discussions to decision-points

• Ability to collaborate and manage conflict in a fast-pace environment, working across functions

• Excellent interpersonal, verbal and written communication skills