Operation Support Specialist - Shift 3

Simtra BioPharma Solutions•Bloomington, IN

2d•Onsite

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 assigned shift is 2:30 a.m. to 11:00 a.m., Monday through Friday; shift coverage may vary according to business need. The Specialist supports deviation investigations from event response through closure, including documenting event chronology, providing impact assessment input, analyzing root causes, determining corrective and preventive action rationale, coordinating subject matter expert input, and maintaining inspection-ready records. The role also supports CAPAs and continuous improvement, communicates across shifts and functions, and helps colleagues strengthen event documentation and GMP practices while not replacing QA decision authority. Simtra BioPharma Solutions is a contract development and manufacturing organization with facilities in Bloomington, Indiana, and Halle/Westfalen, Germany. It partners with pharmaceutical and biotechnology companies to manufacture sterile injectable products and provides services including formulation and development, lyophilization optimization, regulatory support, and secondary packaging.

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 execute 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 walking or standing for periods of time.

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 colleagues during operational events to understand what happened, potential impact, immediate actions, and information to preserve for the 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 partners to support a safe, compliant return to operations.
Author assigned manufacturing deviations with clear, technically sound investigations covering chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence.
Use structured root cause tools, such as 5 Whys, fishbone/Ishikawa, fault tree, process mapping, human performance analysis, and data trending, as appropriate.
Drive assigned deviations to timely closure and coordinate input from Manufacturing, QA, Engineering, MSAT, Validation, Microbiology, Training, and other subject matter experts.
Meet the expected productivity of approximately three to four deviation closures per month, with expectations adjusted for complexity and business priorities.
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 and lead or support continuous improvement actions.
Build credibility with manufacturing operators and leaders, QA representatives, and technical support functions through visibility, responsiveness, and practical support on the manufacturing floor.
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 mindsets without replacing QA decision authority.
Maintain accurate, timely, traceable, inspection-ready investigation and 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.