Pharma Ops Support & Deviation Lead

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Paid Holidays

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, IN, seeks an Operations Support Specialist to partner with manufacturing and QA on deviation events, CAPA actions, and continuous improvement initiatives. You will author investigations, ensure timely closures, and support operational recovery after incidents.

The role emphasizes strong technical writing, root-cause analysis, and cross-functional collaboration in a fast-paced GMP environment, with scheduled shifts 2:30am–11am Monday–Friday.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 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 with the ability to translate complex manufacturing events into clear, factual narratives.
• Experience in sterile, aseptic, pharmaceutical, biotechnology, or other highly regulated manufacturing operations preferred.
• Ability to execute multiple investigations and CAPA actions while maintaining attention to detail, compliance, safety, and product quality.

Responsibilities

• On-shift Deviation Event Response: Partner with Manufacturing and QA to understand what happened and what information must be preserved.
• Capture critical event details such as timing, equipment state, batch identifiers, personnel involved, and process parameters.
• Support timely initiation of deviation investigations and clear handoffs across shifts and weekends.
• Help Operations return online after incidents by coordinating with Manufacturing, QA, Engineering and other partners while maintaining quality.
• Serve as a primary author for manufacturing deviations assigned to Operations Support.
• Write complete, clear investigations including chronology, root cause, actions and objective evidence.
• Use root cause tools like 5 Whys, Ishikawa, fault tree, process mapping, and data trending as appropriate.
• Drive deviation closures timely; coordinate input from SMEs across functions.
• Maintain productivity of 3–4 deviation closures per month, adjusting for complexity and priorities.
• Identify recurring themes to drive CI actions and prevention.
• Own and execute CAPA actions related to processes, training and equipment.
• Lead or support CI actions to improve reliability, aseptic practice and batch readiness.
• Build credibility with operators, QA and leadership through visibility and practical on-floor support.
• Communicate event status, needs, owners and next steps across shifts.
• Participate in shift handoffs and review routines as assigned.
• Coach colleagues on event detail capture and GDP expectations without replacing QA decisions.

Skills

GMP knowledge

Technical writing

Root cause analysis

Quality systems

Communication

Shift work adaptability

Education

Bachelor's degree in Life Sciences or Engineering

Tools

GxP software

Deviation tracking

Job description

Simtra BioPharma Solutions in Bloomington, IN, seeks an Operations Support Specialist to partner with manufacturing and QA on deviation events, CAPA actions, and continuous improvement initiatives. You will author investigations, ensure timely closures, and support operational recovery after incidents.

The role emphasizes strong technical writing, root-cause analysis, and cross-functional collaboration in a fast-paced GMP environment, with scheduled shifts 2:30am–11am Monday–Friday.