Senior Specialist, Aseptic Control

Resilience; Port Union (OH); On-site; USD 75,000 - 116,000; Full time

Benefits offered by this job

Annual bonus program

401(k) plan with company match

Comprehensive healthcare benefits

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience, Inc. in the United States is seeking a Senior Analyst, QC Micro – Aseptic to own the environmental monitoring program and drive regulatory-compliant improvements across the site.

You will review EM data, approve packages, and escalate complex issues with cross-functional teams. The role requires strong leadership, technical writing, and problem-solving, with experience in LEAN manufacturing and familiarity with LDMS/Veeva, SAP, and MODA.

Qualifications

• Demonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality.
• Ability to own a technical program end-to-end and drive improvements independently.
• Experience leading technical programs in a regulated pharma setting with cross-functional alignment.

Responsibilities

• Environmental Monitoring Execution & Data Review, including EM trending and EMPQ.
• Serve as final technical reviewer/approver for EM data packages and deviations.
• Respond to compliance questions from regulators and internal teams.
• Develop and maintain the EM program in regulatory compliance.
• Lead complex investigations, impact assessments, and mitigations.
• Represent the Aseptic Control Team on deviation/change management.
• Lead process improvement activities and cross-functional alignment.
• Provide training and coaching on EM data interpretation and compliance.
• Fill in for manager on technical/compliance matters as needed.

Skills

Environmental monitoring

Aseptic control

Cross-functional leadership

Regulatory compliance

Quality systems

Education

Bachelor's degree in engineering, pharmacy, or related scientific discipline

Tools

LDMS

Veeva

SAP

MODA or equivalent

Job 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.comThe Senior Analyst, QC Micro – Aseptic serves as the technical authority for the site environmental monitoring and aseptic control program, independently owning EM program integrity, proactively driving improvement across the program, and advising the team and cross-functional partners on complex compliance matters without being directed to do so.Job ResponsibilitiesEnvironmental Monitoring Execution & Data ReviewOwn environmental monitoring trending (monthly, quarterly, annual), EMPQ and related document updates, and associated deviations and investigationsServe as final technical reviewer and approver for EM data packages and for production and lab documentation escalated by the EM team, including cGMP compliance determinationsRespond to compliance and process questions, including from regulatory agenciesDevelop and maintain the environmental monitoring program in regulatory complianceLead complex investigations, impact assessments, and mitigationsRepresent the Aseptic Control Team on deviation and change management committeesLead process improvement activitiesProactively identify gaps in the EM program, develop recommendations, and drive cross-functional alignment around solutionsTraining & Team SupportDevelop and deliver technical training and qualification content for EM and aseptic control personnel, and assess ongoing competencyCoach analysts and technicians on data interpretation, investigation methodology, and compliance decision-makingServe as the technical escalation point for the EM team on compliance questions falling outside established proceduresFill in for direct manager on technical and compliance matters as neededExperience & EducationMinimum RequirementsDemonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality; able to advise the team and drive improvements independently, including on novel and complex compliance mattersDemonstrated ability to own a technical program end-to-end - setting the direction, proactively identifying gaps, and driving resolution of complex compliance problems without being directed to do soExperience leading technical programs or projects in a regulated pharmaceutical setting, with cross-functional alignment-building on technical issuesStrong communication and leadership skillsStrong mechanical, troubleshooting, and problem-solving abilitiesAbility to direct and participate in cross-functional teamsStrong technical and scientific writingProject management skillsDemonstrated ability to influence the technical decisions and priorities of peers and cross-functional partners through expertise and credibility, without requiring formal authorityPreferred RequirementsBachelor's degree in engineering, pharmacy, or a related scientific discipline5+ years in pharmaceutical QC or environmental monitoringExperience working in a LEAN manufacturing environmentWorking knowledge of LDMS or Veeva, Microsoft applications, SAP, and MODA or equivalentPhysical & Work EnvironmentThis is primarily a non-sedentary role.Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.Occasional (20–60% of time): sitting, walking, and monitoring other people's work.Infrequent (<20% of time): lifting/carrying up to 30 lbs., working at heights of 5 ft., bending, stooping, twisting, reaching, noise exposure, operating moving machinery, chemical usage with potential exposure to area chemicals requiring handling precautions per SOP, traveling, and speaking publicly.Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors; seeing with 20/20 (or better) vision, with or without correction.All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.Work ScheduleMonday - Friday 8 hours, Monday -Thursday 10 hoursThe work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This role requires the ability to provide 24/7 on-call support as needed.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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $75,000.00 - $116,250.00 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? We encourage you to apply and start a conversation with one of our recruiters.