Senior Specialist II, Technical Quality (Sterile Ops) at Resilience

West Chester, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

132500.0

Posted On

15 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Expertise, Quality Assurance, Leadership, Regulatory Compliance, Validation Protocols, Investigations, Technology Transfer, Risk Assessment, Problem-Solving, Interpersonal Skills, Technical Writing, Continuous Improvement, GMP Knowledge, Aseptic Manufacturing, Root Cause Analysis, Project Management

Industry

Pharmaceutical Manufacturing

Description

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 Technical Quality Senior Specialist II 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 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. Job 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. 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. Experience with sterile manufacturing processes. Previous experience in leading or supporting regulatory inspections and audits. The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not available for this position. 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. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $95,000.00 - $132,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters. 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. Join Our Talent Community Don't see a posting that's the right fit? Join our talent community to be considered in our talent pool and we'll reach out if the right opportunity arises. RESILIENCE 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. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites

Responsibilities

The Senior Specialist II is responsible for providing quality oversight for complex investigations, validation protocols, and technology transfer documents. They lead initiatives to enhance product quality and ensure compliance with regulatory standards.