Sr Manufacturing Engineer

Job Description

Validation \& Engineering Group Inc V\&EG a Pinnaql company 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 ethical standards for the following position Sr Manufacturing EngineerThe Senior Manufacturing Engineer leads enterprise manufacturing operations support validation strategy implementation of manufacturing processes documentation generation process optimization and cross functional technical execution The role is expected to operate with a high degree of independence provide technical leadership to project teams and mentor junior engineers or technical team members as needed Key Responsibilities Lead IQOQPQ and process performance qualification activities; develop validation protocols reports and master validation plansDesign and develop in process and receiving inspection systems control plans sampling plans and inspection methods for components and manufacturing processesGenerate review and approve equipment documentation PMcalibration procedures manufacturing instructions and process control documentationManage enterprise manufacturing projects from concept through implementation; lead cross functional technical collaboration with Manufacturing Quality R\&D Regulatory Supply Chain and external suppliers as applicableApply DOE PFMEA risk analysis SPC MSA and root cause methodologies to characterize optimize and improve manufacturing processesLead Lean Manufacturing and continuous improvement initiatives to improve yield cycle time cost throughput process capability and equipment performanceProvide technical direction for manufacturing technologies such as laser welding heat bonding injection molding vision systems fixtures tooling test methods automation and equipment qualificationSupport change control CAPA nonconformance investigations and productprocess scale up activities while maintaining compliance with site quality proceduresExperience Requirements Bachelors degree in Mechanical Electrical Industrial Manufacturing Biomedical Engineering or related technical field5 7 years in manufacturing engineering process engineering validation engineering or quality engineering within an FDA regulated environmentStrong working knowledge of 21 CFR Part 820 GMP ISO 13485 and documentation practices required in regulated manufacturing environmentsElectrical and mechanical engineering background applied to automated or semi automated manufacturing systemsExperience with automationcontrols tooling fixtures test method development equipment qualification and manufacturing process validationProficiency in DOE FMEAPFMEA CAPA root cause investigation statistical analysis and process capability tools; experience with Minitab JMP or equivalent preferredExperience with Lean Manufacturing Six Sigma Kaizen value stream mapping or other continuous improvement methodologies preferredExperience supporting product introductions process scale up design transfer and improvements to existing manufacturing processesStrong project management communication technical writing analytical and cross functional leadership skillsQuality Expectations Demonstrates commitment to patient safety and product quality by complying with all applicable quality proceduresEnsures proper documentation discipline and supports Quality System compliance while providing technical guidance to others as neededAt Validation \& Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you Validation \& Engineering Group is an equal opportunity employer All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status