Operation Support Specialist - Weekend PM

Simtra BioPharma Solutions•Bloomington, IN

About The Position

The Operations Support Specialist is an embedded Operations partner assigned to support manufacturing shifts within an Operations Focus Factory. Working directly with Manufacturing and Quality colleagues during operational events, the Specialist captures critical event details, supports timely deviation initiation, and helps coordinate a safe, compliant return to operations. The role is a primary author of manufacturing deviations, with an expected workload of approximately three to four deviations written and closed per month, depending on event volume and complexity. The Specialist drives assigned deviations, CAPAs, and continuous improvement actions related to manufacturing processes, and provides oversight of CAPA effectiveness after implementation. The position collaborates with Manufacturing, QA, Engineering, Maintenance, Validation, MSAT, Microbiology, Training, and other subject matter experts. It also supports investigation readiness, quality-system compliance, shift handoffs, and continuous improvement across manufacturing operations. The assigned schedule is 3:00 p.m. to 1:30 a.m., Friday through Monday. Duties may require overtime, including nights and weekends. The work may involve long periods of sitting as well as periods of walking or standing, and appropriate personal protective equipment must be worn as applicable.

Requirements

Bachelor's degree in Life Sciences, Engineering, or a related field; equivalent relevant experience may be considered in accordance with HR guidance.
Ability to work assigned shift coverage, including 2nd shift, 3rd shift, Weekend AM, or Weekend PM, as assigned by business need.
Strong written communication skills and ability to translate complex manufacturing events into clear, factual, logically structured investigation narratives.
Demonstrated ability to work effectively with Manufacturing, QA, technical subject matter experts, and site support functions in a fast-paced production environment.
Ability to manage multiple investigations and CAPA actions while maintaining attention to detail, compliance, safety, and product quality.
Must wear appropriate personal protective equipment as applicable.
Use of hands and fingers to manipulate office equipment is required.
Position requires sitting for long hours and may involve periods of walking or standing.

Nice To Haves

Working knowledge of GMP documentation practices, data integrity principles, deviation investigations, root cause analysis, and CAPA execution.
Experience in sterile, aseptic, pharmaceutical, biotechnology, or other highly regulated manufacturing operations.

Responsibilities

Partner with Manufacturing and QA during operational events to understand what happened, what was impacted, what immediate actions were taken, and what information must be preserved.
Capture timely, critical event details, including timing, equipment state, batch or material identifiers, personnel involved, process parameters, alarms, documentation status, area conditions, and containment actions.
Support timely initiation of deviation investigations and ensure clear handoffs when events span shifts or weekends.
Coordinate with Manufacturing, QA, Engineering, Maintenance, Validation, and other partners to support a safe and compliant return to operations.
Author manufacturing deviation investigations with clear event chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence.
Use appropriate structured root cause analysis tools, such as 5 Whys, fishbone/Ishikawa, fault tree, process mapping, human performance analysis, and data trending.
Drive assigned deviations to timely closure while coordinating input from subject matter experts and support functions.
Identify recurring event themes, process vulnerabilities, documentation gaps, human-factor contributors, training opportunities, and equipment or workflow issues for potential continuous improvement actions.
Own and execute assigned CAPA actions related to manufacturing processes, documentation, training, equipment interfaces, behavior-based errors, process controls, and recurring operational issues.
Lead or support continuous improvement actions to improve manufacturing reliability, right-first-time execution, aseptic practice, documentation accuracy, downtime recovery, and batch release readiness.
Communicate event status, investigation needs, action owners, and next steps clearly across shifts and functions.
Participate in shift handoffs, tier meetings, deviation review routines, CAPA progress reviews, and Focus Factory performance discussions as assigned.
Coach manufacturing colleagues on event detail capture, GDP expectations, deviation readiness, and prevention practices, without replacing QA decision authority.
Maintain accurate, timely, traceable, and inspection-ready investigation records, CAPA records, objective evidence, and supporting documentation.
Follow applicable GMP, data integrity, deviation, CAPA, continuous improvement, change control, training, and document control procedures.
Promptly escalate quality, safety, compliance, or supply risks through established channels.