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 Manufacturing EngineerRole Summary The Manufacturing Engineer supports enterprise manufacturing operations by assisting with validation activities documentation generation manufacturing instructions data analysis and process improvement initiatives under the guidance of senior engineering and cross functional team members Key Responsibilities Support IQOQPQ and process performance qualification activities by assisting with validation protocols reports test execution and related documentationAssist in developing in process and receiving inspection systems basic control plans sampling plans and inspection methods for components and manufacturing processesGenerate and maintain equipment documentation PMcalibration procedures manufacturing instructions and process documentation with guidance from senior engineersSupport enterprise manufacturing projects from concept through implementation; participate in cross functional collaboration with Manufacturing Quality R\&D Regulatory and Supply Chain as applicableApply basic DOE FMEAPFMEA risk analysis SPC and root cause tools to support process characterization optimization and improvementSupport Lean Manufacturing and continuous improvement activities focused on yield cycle time cost throughput and process documentation improvementsSupport manufacturing technologies such as laser welding heat bonding injection molding vision systems fixtures tooling test methods automation and equipment qualification under technical supervisionAssist with CAPA nonconformance investigations change control and productprocess scale up activities as assignedExperience Requirements Bachelors degree in Mechanical Electrical Industrial Manufacturing Biomedical Engineering or related technical field1 3 years in manufacturing engineering process engineering quality engineering validation or related technical experience within an FDA regulated environment preferredBasic working knowledge of 21 CFR Part 820 GMP ISO 13485 and documentation practices used in regulated manufacturing environments preferredElectrical mechanical industrial or biomedical engineering background applicable to manufacturing systemsExposure to automationcontrols tooling fixtures test methods equipment qualification or process validation preferredFamiliarity with DOE FMEAPFMEA CAPA root cause investigation SPC and process capability conceptsExperience with Microsoft Excel and exposure to Minitab JMP or equivalent statistical tools preferredExposure to Lean Manufacturing Six Sigma Kaizen or other continuous improvement methodologies preferredExposure to product introductions process scale up design transfer or improvements to existing processes preferredStrong analytical communication teamwork technical writing and problem solving 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 with guidance from senior engineers and quality partnersAt 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