Senior Specialist, Aseptic Control

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 ( ​

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.

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.