Senior Specialist, Aseptic Control

## Senior Specialist, Aseptic Control Apply: USA - OH - West Chester:
Full time:
Posted Yesterday: R-107324A 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 (Use the "Apply for this Job" box below). 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 (