Senior Specialist, Aseptic Control

Resilience•West Chester, OH

About The Position

The Senior Specialist, Aseptic Control serves as the technical authority for the site environmental monitoring and aseptic control program. The role independently owns the integrity of the environmental monitoring program, drives improvements, and advises the team and cross-functional partners on complex compliance matters. The position also serves as a technical escalation point and may fill in for the direct manager on technical and compliance matters as needed. The role involves owning environmental monitoring trends and related documentation, reviewing and approving data packages and escalated production and laboratory documentation, responding to compliance questions, and leading investigations and process improvements. It also includes developing and maintaining the environmental monitoring program in regulatory compliance, delivering technical training, and coaching analysts and technicians. This is primarily a non-sedentary role that may require personal protective equipment, including respirators or PAPRs, gowns, gloves, face protection, and other barrier equipment. The stated schedule is Monday–Friday, either 8-hour days or Monday–Thursday, 10-hour days. The role requires the ability to provide 24/7 on-call support as needed. The company may modify schedules and request overtime based on business needs.

Requirements

Demonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality, including the ability to advise the team and independently drive improvements on novel and complex compliance matters.
Demonstrated ability to own a technical program end-to-end by setting direction, proactively identifying gaps, and driving resolution of complex compliance problems without being directed.
Experience leading technical programs or projects in a regulated pharmaceutical setting and building cross-functional alignment 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 skills.
Project management skills.
Demonstrated ability to influence technical decisions and priorities of peers and cross-functional partners through expertise and credibility, without formal authority.
Ability to provide 24/7 on-call support as needed.

Nice To Haves

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.

Responsibilities

Own environmental monitoring trending (monthly, quarterly, and annual), EMPQ and related document updates, and associated deviations and investigations.
Serve as the final technical reviewer and approver for environmental monitoring data packages and production and laboratory documentation escalated by the EM team, including cGMP compliance determinations.
Respond to compliance and process questions, including questions 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 environmental monitoring program gaps, develop recommendations, and drive cross-functional alignment around solutions.
Develop and deliver technical training and qualification content for environmental monitoring 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 environmental monitoring team on compliance questions outside established procedures.
Fill in for the direct manager on technical and compliance matters as needed.
Adhere to the Quality Management System, Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and other applicable regulations and standards.