Senior Specialist, Aseptic Control

Resilience, Inc.; Olde West Chester (OH); On-site; USD 75,000 - 116,000; Full time

Benefits offered by this job

5 days of PTO

401k match

Health benefits

Job summary

Resilience, Inc. is seeking a Senior Analyst, QC Micro – Aseptic in the United States to own the environmental monitoring program and drive aseptic control improvements.

You will independently manage EM program integrity, review data packages, and advise cross-functional teams on complex compliance matters. You will lead EM data reviews, mentor analysts, and collaborate with production and quality teams to ensure cGMP adherence while guiding investigations and deviations to successful

Qualifications

• Demonstrated 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 so
• Demonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality; advise and improve independently
• Experience leading programs or projects in a regulated pharmaceutical setting with cross-functional alignment

Responsibilities

• Own environmental monitoring trending (monthly, quarterly, annual) and related documentation
• Serve as final technical reviewer and approver for EM data packages and for production/lab docs with cGMP determinations
• Respond to regulatory and compliance questions from agencies
• Develop and maintain the environmental monitoring program in regulatory compliance
• Lead complex investigations, impact assessments, and mitigations
• Represent the Aseptic Control Team on deviation/change management committees
• Lead process improvement activities and drive cross-functional alignment
• Identify gaps in the EM program and propose solutions

Skills

Environmental monitoring

Aseptic control

Pharmaceutical quality

Regulatory compliance

Education

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

Tools

LDMS

Veeva

Microsoft apps

SAP

MODA

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.com

The 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 Responsibilities

Environmental Monitoring Execution & Data Review

• Own environmental monitoring trending (monthly, quarterly, annual), EMPQ and related document updates, and associated deviations and investigations
• Serve as final technical reviewer and approver for EM data packages and for production and lab documentation escalated by the EM team, including cGMP compliance determinations
• Respond to compliance and process questions, including from regulatory agencies
• Develop and maintain the environmental monitoring program in regulatory compliance
• Lead complex investigations, impact assessments, and mitigations
• Represent the Aseptic Control Team on deviation and change management committees
• Lead process improvement activities
• Proactively identify gaps in the EM program, develop recommendations, and drive cross-functional alignment around solutions

Training & Team Support

• Develop and deliver technical training and qualification content for EM and aseptic control personnel, and assess ongoing competency
• Coach analysts and technicians on data interpretation, investigation methodology, and compliance decision-making
• Serve as the technical escalation point for the EM team on compliance questions falling outside established procedures
• Fill in for direct manager on technical and compliance matters as needed

Experience & Education

Minimum Requirements

• Demonstrated 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 matters
• Demonstrated 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 so
• Experience leading technical programs or projects in a regulated pharmaceutical setting, with cross-functional alignment-building on technical issues
• Strong communication and leadership skills
• Strong mechanical, troubleshooting, and problem-solving abilities
• Ability to direct and participate in cross-functional teams
• Strong technical and scientific writing
• Project management skills
• Demonstrated ability to influence the technical decisions and priorities of peers and cross-functional partners through expertise and credibility, without requiring formal authority

Preferred Requirements

• Bachelor's degree in engineering, pharmacy, or a related scientific discipline
• 5+ years in pharmaceutical QC or environmental monitoring
• Experience working in a LEAN manufacturing environment
• Working knowledge of LDMS or Veeva, Microsoft applications, SAP, and MODA or equivalent

Physical & Work Environment

This 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 Schedule

Monday - Friday 8 hours, Monday -Thursday 10 hours

The 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.

Equal Employment Opportunity Statement

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.