Operation Support Specialist - Shift 2

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 with on-shift Manufacturing and Quality colleagues during operational events to support deviation response, capture critical details, initiate deviations promptly, and support the safe, compliant return of operations after incidents. The Specialist serves as 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 role also owns and drives assigned CAPAs and continuous improvement actions related to manufacturing processes and oversees CAPA effectiveness after implementation. The specified shift is 2:30 p.m. to 11 p.m., Monday through Friday; coverage may also include other shifts or weekends as assigned by business need. The role collaborates across Manufacturing, Quality Assurance, Engineering, Maintenance, Validation, MSAT, Microbiology, Training, and other subject matter experts. It supports compliant, inspection-ready records and helps improve manufacturing reliability, right-first-time execution, aseptic practices, documentation accuracy, downtime recovery, and batch release readiness.

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, what was impacted, immediate actions taken, and what information must be preserved.
Capture 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 clear handoffs when events span shifts or weekends.
Coordinate with Manufacturing, QA, Engineering, Maintenance, Validation, and other partners to support the safe, compliant return of operations after incidents.
Serve as a primary author for assigned manufacturing deviations and write complete, clear, technically sound investigations.
Document event chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence.
Use structured root-cause tools, including 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 relevant subject matter experts.
Maintain expected productivity of approximately three to four deviation closures per month, adjusted for complexity, 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 manufacturing and technical colleagues 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 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.
Perform other duties as assigned.

Benefits

Medical and dental coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Short- and Long-Term Disability Insurance
Voluntary Insurance Benefits
Vision Coverage
Accident Insurance
Critical Illness Insurance
Hospital Indemnity Insurance
Identity Theft Protection
Legal benefits
Onsite campus amenities, including a workout facility, cafeteria, and credit union