The Junior / Associate Process Engineer provides hands‑on technical and execution support for manufacturing processes, validations, and investigations at the site. The role focuses on execution‑level process engineering activities, including data collection, validation support, manufacturing floor support, and troubleshooting, particularly during process transfers, integrations, and early‑phase manufacturing activities. This position supports efficient workload distribution within process engineering while enabling development of practical, hands‑on process expertise. To perform this job successfully, an individual must be able to capably perform each of the following essential duties: Support equipment, utility, process, labeling, and shipping validations, including study setup, execution, data collection, documentation, and report completion across short‑ and medium‑term project timelines.Perform historical data extraction, compilation, and preliminary analysis to support CAPA, NCR/OOS investigations, trending, and process improvement activities.Provide hands‑on manufacturing floor support during routine production, including real‑time process monitoring, issue identification, and troubleshooting in laboratory and manufacturing environments.Assist with process integration and stabilization activities, including increased troubleshooting and investigation support during early operational phases under established procedures.Support process optimization and continuous improvement initiatives by identifying execution‑level opportunities and implementing approved changes under supervisor guidance.Prepare and maintain validation protocols, reports, memos, batch documentation, and investigation records in accordance with GMP and internal requirements.Collaborate routinely with Manufacturing, Quality Control, Quality Assurance, and Process Engineering teams to support operations while minimizing disruption to core production and compliance activities.Execute assigned work in accordance with SOPs, work instructions, GMP, safety, and PPE requirements, escalating issues as appropriate.Perform other duties as assigned to meet business needs.
