Ll02-122024 Validation Specialist – Process Equipment (Syringe Filling Lines)

Validation & Engineering Group

Juncos, PR
Permanente
Tiempo completo

Hace 12 días

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Commissioning and Qualification Specialist – Process Equipment (Syringe Filling Lines)Position SummaryThe Commissioning and Qualification (C&Q) Specialist for Process Equipment will lead and execute the commissioning and qualification activities for syringe filling lines in a regulated GMP environment. The role requires expertise in process equipment validation, including filling, stoppering, sealing, and inspection systems. The C&Q Specialist ensures compliance with industry regulations, quality standards, and project timelines while collaborating with cross-functional teams to support new installations, upgrades, and lifecycle management.Key Responsibilities1. Commissioning ActivitiesDevelop and execute commissioning protocols for syringe filling lines and associated equipment (e.g., isolators, conveyors, filling pumps, and inspection systems).
Perform factory acceptance testing (FAT), site acceptance testing (SAT), and start-up activities to ensure equipment functionality and performance.
Identify and resolve technical issues encountered during commissioning.2. Qualification & ValidationAuthor, review, and execute qualification protocols (IQ, OQ, PQ) for syringe filling lines and auxiliary equipment.
Perform critical parameter testing, including aseptic filling process validation, media fills, and sealing integrity testing.
Conduct risk assessments and ensure qualification aligns with regulatory and quality requirements.3. DocumentationDevelop and maintain all C&Q documentation, including protocols, reports, and supporting data.
Ensure accurate traceability and alignment with the validation master plan (VMP).
Document and manage deviations, CAPAs, and change control processes related to process equipment.4. Compliance and Regulatory AdherenceEnsure all activities comply with regulatory requirements, including FDA, EMA, and ISO standards.
Support data integrity initiatives and compliance with 21 CFR Part 11 and Annex 11 for computerized systems.
Prepare for and support regulatory audits and inspections.5. Lifecycle ManagementOversee equipment requalification, periodic reviews, and performance monitoring.
Support decommissioning activities for obsolete equipment while maintaining documentation records.
Partner with maintenance and engineering teams for equipment calibration and troubleshooting.6. Cross-Functional CollaborationCollaborate with manufacturing, engineering, quality assurance, and validation teams during project execution.
Work closely with equipment vendors to ensure timely delivery, setup, and qualification.
Act as a subject matter expert (SME) for syringe filling line operations and qualification during audits.7. TrainingTrain operators and technicians on proper use and maintenance of qualified process equipment.Qualifications:EducationBachelor's degree in Engineering (Mechanical, Chemical, or Industrial), Biotechnology, or a related technical field.Experience5+ years of experience in commissioning, qualification, and validation of process equipment in pharmaceutical or biopharmaceutical manufacturing.
Hands-on experience with syringe filling equipment, isolators, and automated systems.
Familiarity with aseptic processing and sterile manufacturing principles.SkillsStrong technical writing skills for protocol development and report generation.
Proficient in process risk assessment tools (e.g., FMEA, HAZOP).
Strong project management and organizational skills.
Effective communication and problem-solving abilities for cross-functional collaboration.KnowledgeIn-depth knowledge of GMP, FDA, EMA, and ISO 13485 regulations.
Familiarity with process validation principles (e.g., ICH Q8/Q9/Q10).
Experience with equipment automation systems and SCADA platforms.Preferred QualificationsCertification in C&Q, validation, or process engineering (e.g., ISPE, PDA).
Experience with automated visual inspection and serialization systems.
Knowledge of Lean Manufacturing or Six Sigma methodologies.Working ConditionsManufacturing plant environment.
Flexibility to work extended hours or weekends during critical project phases.
Occasional travel to vendor facilities for FATs or training.

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