CON TSMS Process Scientist 2026
Listed on 2026-08-18
-
Manufacturing / Production
Validation Engineer, Manufacturing Engineer, Quality Engineering
Position Overview
Our client is seeking an experienced Technical Services/Manufacturing Sciences (TS/MS) Process Scientist to provide hands-on technical support within an active pharmaceutical manufacturing environment.
This role is designed for a scientist who has spent significant time embedded within live manufacturing operations and owned a process or product line over time
. The Process Scientist will serve as a key resource for manufacturing personnel, providing on-floor troubleshooting, investigating manufacturing events, supporting process execution, and maintaining ownership of manufacturing processes.
The ideal candidate has supported commercial or scale-up manufacturing operations on an ongoing basis and understands the day-to-day ownership required after a process has been implemented.
Key Responsibilities Manufacturing Floor & Process Support- Serve as an embedded resource supporting active manufacturing operations.
- Provide hands-on guidance to operators and manufacturing personnel during production.
- Maintain sustained ownership of assigned manufacturing processes and/or product lines.
- Troubleshoot process issues and respond to unexpected events occurring during manufacturing.
- Evaluate process performance and provide scientifically sound recommendations to Manufacturing and Quality.
- Recognize when manufacturing issues require escalation and engage the appropriate technical, quality, engineering, or leadership resources.
- Support implementation and execution of downtime discard policies.
- Lead or directly support deviation investigations resulting from actual manufacturing-floor events
. - Perform root cause analysis and develop technically sound corrective and preventive actions (CAPAs).
- Partner with Manufacturing and Quality to assess process and product impact following deviations.
- Monitor CAPA effectiveness and support implementation of improvements within manufacturing operations.
- Use manufacturing data, process knowledge, and direct floor observations to support investigations rather than functioning solely as a documentation resource.
- Own, review, and revise batch records, manufacturing instructions, specifications, and other process documentation supporting commercial or scale-up production.
- Ensure manufacturing documentation accurately reflects established process requirements and technical knowledge.
- Support changes to manufacturing processes, specifications, and production documentation through appropriate change-control processes.
- Maintain technical knowledge of assigned processes throughout their lifecycle.
- Generate, review, and execute Performance Validation (PV) protocols and other manufacturing process studies.
- Assist with development of technical protocols supporting process validation and manufacturing activities.
- Design and/or execute studies such as mixing studies to evaluate formulation homogeneity.
- Support acclimation studies assessing material stability following environmental changes.
- Evaluate study data, document conclusions, and provide technical recommendations.
- Maintain ongoing working relationships across Manufacturing, Quality, R&D, Regulatory, Engineering, and other technical functions
. - Serve as a technical subject matter resource for manufacturing personnel.
- Train and mentor scientists, technicians, and/or manufacturing operators on processes, technical requirements, and troubleshooting.
- Communicate technical issues and recommendations effectively to both technical and operations personnel.
- Support knowledge transfer and continuous improvement across the manufacturing organization.
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or another relevant scientific or technical discipline.
- 5+ years of relevant pharmaceutical or biopharmaceutical manufacturing experience preferred.
- Demonstrated experience providing sustained, hands-on technical support within live manufacturing operations
. - Experience owning or supporting a manufacturing process or product line through ongoing commercial or scale-up production.
- Direct experience investigating manufacturing deviations and supporting CAPA development and execution
. - Experience owning, authoring, or revising batch records and/or product/process specifications associated with manufacturing.
- Experience generating and executing process validation or manufacturing study protocols.
- Strong process troubleshooting and root cause analysis capabilities.
- Demonstrated ability to work cross-functionally with Manufacturing and Quality.
- Experience with in Technical Services/Manufacturing Sciences (TS/MS), Manufacturing Science and Technology (MSAT/MS&T), Process Sciences, Process Engineering, or a comparable manufacturing technical support function
. - Experience supporting formulation, filling, and/or visual inspection operations.
- Experience…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).