Operation Support Specialist - Weekend AM

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. Summary: 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 event response, capture critical details, help initiate deviations in a timely manner, and support the safe and compliant return of operations after incidents. This 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 provides oversight of CAPA effectiveness after implementation. Shift: 5:00am to 3:30pm (Friday - Monday) Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): On-shift Deviation Event Response - Partner with Manufacturing and QA colleagues at the time of an operational event to understand what happened, what was impacted, what immediate actions were taken, and what information must be preserved for the investigation. - Capture critical event details while the information is fresh, including timing, equipment state, batch or material identifiers, personnel involved in execution, process parameters, alarms, documentation status, environmental or area conditions, and containment actions. - Support timely initiation of the deviation investigation process and ensure handoffs are clear when events span shifts or weekends. - Help Operations return online after an incident by coordinating with Manufacturing, QA, Engineering, Maintenance, Validation, and other partners as appropriate, while maintaining quality and compliance expectations. Deviation Investigation Authoring - Serve as a primary author for manufacturing deviations assigned to Operations Support. - Write complete, clear, and technically sound investigations that include event chronology, impact assessment input, immediate actions, root cause analysis, corrective / preventive action rationale, and appropriate 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 to deviation complexity. - Drive assigned deviations to timely closure while coordinating input from Manufacturing, QA, Engineering, MSAT, Validation, Microbiology, Training, or other Subject Matter Experts. - Maintain expected productivity of approximately three to four deviation closures per month, with workload expectations adjusted for deviation complexity, business priorities, and quality system requirements. - Support identification of recurring event themes, process vulnerabilities, documentation gaps, human-factor contributors, training opportunities, and equipment / workflow issues that should be converted into Continuous Improvement (CI) actions. - As appropriate, 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 by being visible, responsive, and practical on the manufacturing floor. - 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 effective event detail capture, GDP expectations, deviation readiness, and prevention mindsets without replacing QA decision authority. Compliance, Documentation, and Inspection Readiness - Maintain investigation records, CAPA records, objective evidence, and supporting documentation in a manner that is accurate, timely, traceable, and inspection-ready. - Follow applicable GMP, data integrity, site deviation, CAPA, continuous improvement, change control, training, and document control procedures. - Escalate quality, safety, compliance, or supply risks promptly through established channels. Job Requirements (Education, Experience and Qualifications): Required Qualifications - Bachelors degree in Life Sciences, Engineering, or 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 with the ability to translate complex manufacturing events into clear, factual, and logically structured investigation narratives. - Demonstrated ability to work effectively with Manufacturing, QA, technical SMEs, 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. Preferred Qualifications - 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. Key Competencies - Shop floor presence and credibility - Timely event detail capture - Technical writing clarity - Root cause analysis - CAPA ownership and follow-through - Shift-based collaboration - GMP / GDP discipline - Continuous improvement mindset Key Performance Indicators - Three to four manufacturing deviations written and closed per month, adjusted for complexity and business priorities. - Deviation closure cycle time and right-first-time investigation quality. - Timeliness and completeness of event detail capture and investigation initiation after manufacturing incidents. - CAPA action completion timeliness and quality of objective evidence. - Operational performance enabled through faster, compliant return-to-production support after incidents. - Stakeholder feedback from Manufacturing, QA, and Focus Factory leadership on responsiveness, clarity, and partnership. Physical / Safety Requirements: - Must wear appropriate personal protective equipment as applicable. - Duties may require overtime work, including nights and weekends - Use of hands and fingers to manipulate office equipment is required - Position requires sitting for long hours but may involve walking or standing for periods of time. In return, you’ll be eligible for: - Day One Benefits - Medical & 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 and more - Adoption Reimbursement Program - Education Assistance Program - Employee Assistance Program - Community and Volunteer Service Program - Employee Ownership Plan - Additional Benefits - Short and Long-Term Disability Insurance - Voluntary Insurance Benefits - Vision Coverage - Accident - Critical Illness - Hospital Indemnity Insurance - Identity Theft Protection - Legal and more - Onsite Campus Amenities - Workout Facility - Cafeteria - Credit Union Current benefit offerings are in effect through 12/31/26 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy: Privacy Policy — Simtra BioPharma Solutions