Operation Support Specialist - Weekend AM

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. The Specialist works directly with on-shift Manufacturing and Quality colleagues during operational events to support deviation response, capture critical details, help initiate deviations promptly, and support a safe and compliant return to operations after incidents. The role is a primary author of manufacturing deviations and is expected to write and close approximately three to four deviations per month, depending on event volume and complexity. The Specialist also owns and drives assigned CAPAs and continuous improvement actions related to manufacturing processes and oversees CAPA effectiveness after implementation. The position supports timely and accurate deviation investigations, including event chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence. It collaborates with Manufacturing, QA, Engineering, MSAT, Validation, Microbiology, Training, and other subject matter experts, and contributes to continuous improvement, manufacturing reliability, compliant production recovery, and inspection readiness. The assigned shift is 5:00 a.m. to 3:30 p.m., Friday through Monday. The role requires appropriate personal protective equipment as applicable. Duties may require overtime, including nights and weekends, and the position involves long periods of sitting as well as possible periods of walking or standing.

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 second shift, third 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.
Duties may require overtime, including nights and weekends.
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 and data integrity principles.
Working knowledge of 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, assess impacts and immediate actions, and identify information to preserve for investigation.
Capture event details, including timing, equipment state, batch or material identifiers, personnel involved, process parameters, alarms, documentation status, environmental or area conditions, and containment actions.
Support timely initiation of deviation investigations and clear handoffs when events span shifts or weekends.
Coordinate with Manufacturing, QA, Engineering, Maintenance, Validation, and other appropriate partners to support a safe, compliant return to operations.
Author complete, clear, technically sound manufacturing deviation investigations, including chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence.
Use structured root cause analysis tools appropriate to the complexity of each deviation, such as 5 Whys, fishbone/Ishikawa, fault tree, process mapping, human performance analysis, and data trending.
Drive assigned deviations to timely closure by coordinating input from relevant subject matter experts and functions.
Maintain expected productivity of approximately three to four deviation closures per month, adjusted for complexity, business priorities, and quality system requirements.
Identify recurring event themes, process vulnerabilities, documentation gaps, human-factor contributors, training opportunities, and equipment or workflow issues for possible 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 that improve manufacturing reliability, right-first-time execution, aseptic practice, documentation accuracy, downtime recovery, and batch release readiness.
Build credibility with operators, group leaders, supervisors, QA representatives, and technical support functions through visible, responsive, practical shop-floor partnership.
Communicate event status, investigation needs, action owners, and next steps 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, inspection-ready investigation records, CAPA records, objective evidence, and supporting documentation.
Follow applicable GMP, data integrity, site deviation, CAPA, continuous improvement, change control, training, and document control procedures.
Promptly escalate quality, safety, compliance, or supply risks through established channels.