Process owner Nested Syringes, Vials and Cartridges High Reliability with Type H6-10 (Optima)

Location: Greater Boston AreaType: Full-time / 1099Start: ASAPContextWithin a sterile fill-finish CAPEX environment, you will act as Process Owner for nested formats (syringes, vials, cartridges), ensuring process robustness, GMP compliance, and high-reliability performance (H6–10) from CQV through operational readiness.Scope of WorkProcess OwnershipOwn end-to-end process performance for nested filling operationsEnsure robustness, repeatability, and reliability of aseptic processesMonitor and improve KPIs: yield, rejects, downtime, throughputCQV & Startup SupportSupport FAT, SAT, IQ, OQ, PQ execution and reviewEnsure process readiness for IOQ/PQ and ramp-upInterface with CQV, automation, and engineering teams during startup phasesTroubleshoot process and equipment issues on the shop floorDeviation / CAPA / ComplianceLead investigations (deviations, NCRs) related to process performanceDefine and implement CAPAs with focus on sustainabilityEnsure compliance with GMP / FDA expectationsAct as SME during audits and inspectionsOperational InterfaceAct as point of contact between Manufacturing, MSAT, Quality, and EngineeringSupport batch execution, issue resolution, and process improvementsMaintain SOPs, process documentation, and standardsReliability & Risk ManagementApply risk-based methodologies (FMEA / PFMEA)Drive high-reliability practices (H6–10)Reduce variability, human error, and critical failure modesProfileExperience5–10+ years in sterile manufacturing / fill-finish / MSAT / CQVHands-on experience with:Nested syringes, vials, cartridgesAseptic filling lines (Optima or equivalent preferred)Isolators / RABS / VHPExperience across CQV lifecycle (SAT ? PQ)SkillsStrong knowledge of aseptic processing and contamination controlExperience in deviation management, CAPA, root cause analysisFamiliarity with automation systems (DeltaV, MES) is a plusMindsetHands-on, field-orientedStrong ownership and accountabilityAble to operate in CAPEX / fast-paced environmentsStructured, analytical, solution-drivenAdded Value (EFOR)Exposure to large-scale CAPEX programsIntegration within CQV, MSAT, and engineering teamsOpportunity to contribute to high-reliability manufacturing environments