Validation Engineer IV

General Company Description

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 (general description of the role; e.g. expectations, key milestones, impact)

Reporting to the Senior Validation manager, the Validation Engineer IV role is a member of the Technical Operations team responsible to apply regulatory requirements and industry best practices to develop and implement the overall validation program to support GxP operations at the site. This role will be a subject matter expert and will coordinate qualification and validation activities across multiple functions during start-up of a highly digital biomanufacturing facility. The successful candidate thrives in leading cross-functional teams to achieve challenging goals in a dynamic environment.

Job Responsibilities (core responsibilities; include people management if applicable)

• Own, lead and execute site’s commissioning, qualification, validation, and requalification program, including facility, utilities, manufacturing and lab equipment. Represent validation during tech transfer activities.
• Assist in computer systems validation and Part 11 assessements concurrent to equipment and controlled temperature unit activities.
• Support lab and manufacturing equipment (non-GxP and GxP) life cycle. Work with area owners, finance, quality and IT to define requirements to ensure setup, configuration and maintenance of asset data
• Developing Validation Plans for medium to large size validation projects, maintaining Validation Master Plans and periodic reporting, as well as reviewing and approving peer/vendor CQV protocols and reports
• Write, review and approve various validation related documents (such as: User Requirement Specifications, Failure Mode and Effects Analysis (FMEA) risk assessments for systems and processes, Functional and Design Specifications, plans, protocols, final reports, SOPs, periodic assessments, etc.).
• Developing Validation Plans for medium to large size validation projects, maintaining Validation Master Plans and periodic reporting, as well as reviewing and approving peer/vendor CQV protocols and reports
• Generating complex protocols using a risk based approach that meets current regulatory requirements and industry standards, as well as supporting environmental design qualifications
• Interface with laboratory and operation teams to ensure all facility, utility and equipment CQV needs are fulfilled. Activities include managing both internal and external resources in alignment with approved souricing strategy and providing appropriate oversight
• Support internal and external auditors, including regulatory agencies.

• Supports and manages deviations, investigations, change controls and CAPAs related to GxP maintenance, utilities and building automation systems as it pertains to CQV.
• Other activities and duties as required or assigned

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

• Bachelor’s degree in engineering, life sciences or related field.
• Minimum 8 years of commissioning, qualification, validation experience in the pharmaceutical industry.
• Knowledge of GMPs, FDA and EU guidelines/requirements. Knowledge of OSHA regulations
• Experience with GMP site development and start-up activities including master plan development, risk-based assessment and execution support

• Experience with regulated enterprise asset management (EAM) software (Maximo)
• Experience with electronic Validation Lifecycle Management (eVLM) software (KNEAT Power user preferred)

• Experience working with the FDA and other regulatory agencies
• Knowledge of quality management systems and document control solutions

Other Ideal Personal Characteristics:

• Comfortable in a fast-paced, collaborative small company environment and able to adjust workload based upon changing priorities.
• Strong leadership, customer service, relationship building and communication skills
• Some travels might be required (~5%)

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