Senior Specialist II, Technical Quality (Sterile Operations)

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

The Senior Specialist II, Technical Quality (Sterile Operations) plays a pivotal role in ensuring the technical and operational quality of products, driving continuous improvement in manufacturing processes, and ensuring compliance with regulatory standards. This position requires a blend of strong technical expertise, quality assurance knowledge, and leadership capabilities to effectively collaborate across departments and lead initiatives that enhance product quality and process efficiency. The Senior Specialist II, Technical Quality (Sterile Operations) has advanced technical expertise to be able to provide quality oversight of validation, investigations, and technology transfer. They may work independently or lead specialized projects in their area of expertise, providing high-level strategic insight and technical advice.

Position Responsibilities:

• Provide quality oversight for complex and/or higher-level investigations, validation protocols, and technology transfer documents, ensuring adherence to established specifications, procedures, and regulatory requirements.

• Provide quality oversight, review, and approval of complex and higher-level validation documents including validation plans, requirement documents (URS, FS, SRA, SLIA, and ACA), protocols, data analysis, discrepancies, and final reports.

• Represent the Technical Quality group in project teams, audits, and inspections, as required.

• Provide hands-on support and act as an SME and/or host during internal, regulatory, and customer audits and inspections.

• Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations.

• Provide quality oversight, review, and approval for deviations, CAPAs, Change Controls, and various risk assessments.

• In conjunction with the Lead Investigator, lead major/critical investigations and resolution of product quality issues and non-conformances, ensuring timely and effective corrective actions.

• Drive and support the development and implementation of continuous improvement initiatives to enhance product quality and manufacturing efficiency.

• Ensure manufacturing operations comply with local and global regulatory standards, including but not limited to GMP, FDA, EMA, and ICH guidelines.

• Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process.

• Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle.

• Lead risk assessments (e.g. sFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes.

Minimum Qualifications:

• Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer and process validation, and/or Quality oversight in these disciplines.

• Experience with sterile manufacturing processes.

• Thorough knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation.

• Strong leadership, relationship management, and organizational planning.

• Experience supporting audits and regulatory inspections.

• Experience using risk assessment tools (e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Layers of Protection Analysis (LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools, etc.).

• Expertise in quality management systems.

• Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment.

• Strong interpersonal skills with the ability to lead cross-functional teams and influence without direct authority.

• Excellent written and verbal communication skills, including technical writing for documents and reports.

• Ability and willingness to learn and adapt skills for various areas.

• Ability to travel approximately 5-10% based on project demand.

• Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.

Preferred Qualifications:

• Bachelor's degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field.

• Minimum of 8 years of total combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment.

• Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing.

• Proven track record in technical troubleshooting and root cause analysis.

• Prior cGMP aseptic fill/finish manufacturing experience.

• Experience within a multi-product facility.

• Previous experience in leading or supporting regulatory inspections and audits.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.