Senior Specialist II, Technical Quality (Sterile Operations) Position Available In Chester, Pennsylvania

Job Description:

A career at Resilience is more than just a job – it’s anopportunity to change the future. Resilience is atechnology-focused biomanufacturing company that’s changing the waymedicine is made. We’re building a sustainable network ofhigh-tech, end-to-end manufacturing solutions to better withstanddisruptive events, serve scientific discovery, and reach those inneed. 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 technicaland operational quality of products, driving continuous improvementin manufacturing processes, and ensuring compliance with regulatorystandards. This position requires a blend of strong technicalexpertise, quality assurance knowledge, and leadership capabilitiesto effectively collaborate across departments and lead initiativesthat enhance product quality and process efficiency. The SeniorSpecialist II, Technical Quality (Sterile Operations) has advancedtechnical expertise to be able to provide quality oversight ofvalidation, investigations, and technology transfer. They may workindependently or lead specialized projects in their area ofexpertise, providing high-level strategic insight and technicaladvice.

Position Responsibilities:

Provide quality oversight forcomplex and/or higher-level investigations, validation protocols,and technology transfer documents, ensuring adherence toestablished specifications, procedures, and regulatoryrequirements. Provide quality oversight, review, and approval ofcomplex and higher-level validation documents including validationplans, requirement documents (URS, FS, SRA, SLIA, and ACA),protocols, data analysis, discrepancies, and final reports.

Represent the Technical Quality group in project teams, audits, andinspections, as required. Provide hands-on support and act as anSME and/or host during internal, regulatory, and customer auditsand inspections. Perform reviews and approvals of investigationinitial impact assessments to determine the classification ofdeviations. Provide quality oversight, review, and approval fordeviations, CAPAs, Change Controls, and various risk assessments.

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

Drive and support the development and implementation of continuousimprovement initiatives to enhance product quality andmanufacturing efficiency. Ensure manufacturing operations complywith local and global regulatory standards, including but notlimited to GMP, FDA, EMA, and ICH guidelines. Collaborate withMSAT, Project Management, Engineering, and other departments toensure seamless integration of new products and technologies intothe manufacturing process. Assist in the review and approval of newproduct introductions, ensuring quality standards are metthroughout the product lifecycle. Lead risk assessments (e.g.sFMEA) and implement strategies for mitigating technical andquality risks associated with manufacturing processes.

MinimumQualifications:

Strong technical experience in the qualification ofequipment, utilities, facilities, technology transfer and processvalidation, and/or Quality oversight in these disciplines.

Experience with sterile manufacturing processes. Thorough knowledgeof current industry best practices and regulatory guidanceexpectations regarding technology transfer and validation. Strongleadership, relationship management, and organizational planning.

Experience supporting audits and regulatory inspections. Experienceusing risk assessment tools (e.g. Failure Modes and EffectsAnalysis (FMEA), Hazard Analysis and Critical Control Points(HACCP), Layers of Protection Analysis (LOPA), Preliminary HazardAnalysis (PHA), simple Lean tools, etc.). Expertise in qualitymanagement systems. Excellent problem-solving skills and theability to work under pressure in a fast-paced environment. Stronginterpersonal skills with the ability to lead cross-functionalteams and influence without direct authority. Excellent written andverbal communication skills, including technical writing fordocuments and reports. Ability and willingness to learn and adaptskills for various areas. Ability to travel approximately 5-10%based on project demand. Must have proficient computer skills andbe experienced in Microsoft Office, including Word, Excel,PowerPoint, and Outlook.

Preferred Qualifications:

Bachelor’sdegree or higher in Pharmaceutical Sciences, Chemistry,Engineering, Life Sciences, or related field. Minimum of 8 years oftotal combined experience in quality assurance and/or validationwithin a GMP regulated pharmaceutical and/or biotechnologymanufacturing environment. Direct experience with GMP regulatoryrequirements relevant to pharmaceutical manufacturing. Proven trackrecord in technical troubleshooting and root cause analysis. PriorcGMP aseptic fill/finish manufacturing experience. Experiencewithin a multi-product facility. Previous experience in leading orsupporting regulatory inspections and audits. Resilience is anEqual Employment Opportunity Employer. Qualified applicants willreceive 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, geneticinformation, or characteristic, or other non-job-relatedcharacteristics or other prohibited grounds specified in applicablefederal, state, and local laws. Requests for reasonableaccommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards programincluding an annual cash bonus program, a 401(k) plan with agenerous company match and our benefits package which isthoughtfully designed to support our employees with greathealthcare (including medical, dental and vision), family buildingbenefits, life and disability insurance, flexible time off, paidholidays, other paid leaves of absence, tuition reimbursement andsupport for caregiving needs. Our target base pay hiring range forthis position is $95,000.00 – $132,500.00 per year. Actual base payis dependent upon a number of factors, including but not limitedto, the candidate’s geographical location, relevant experience,qualifications, skills and knowledge. Excited about Resilience andthe biomanufacturing revolution? We encourage you to apply andstart a conversation with one of our recruiters. As a requirementof this role, employees must have the ability to demonstrate andmaintain gown qualification standards. Please review the videobelow, which outlines the most extensive process to gown withinspecific areas of Sterile Operations at Resilience, WestChester.