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Negotiable Salary
Biopeptek Pharmaceuticals
Malvern, PA 19355, USA
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ShareSummary of company: This role is for our sister company - Mainline Scientific is a Malvern, Pennsylvania-based bioanalytical technology company, focusing on developing and manufacturing robust and innovative life science instrumentations. Title: Sr Manufacturing Engineer Department: Manufacturing Report to (title): Manufacturing Manager Location: Malvern, PA Supervisory Responsibility: No FLSA Status: Exempt Position Type: Full - time Travel Required: Yes, occasionally Expected Hours of Work: 40 hours a week M-F 9-5 in office Summary/Objective We are seeking a skilled and motivated Sr Manufacturing Engineer to join our team in supporting the production of advanced analytical instruments. In this role, you will work closely with R&D engineers to bridge product design and manufacturing, playing a key role in process development, production line setup, and continuous improvement initiatives. This position is ideal for someone who is hands-on, detail-oriented, and passionate about quality, efficiency, and innovation in manufacturing. Description Essential Duties and Responsibilities Collaborate with R&D engineers to design and develop scalable and robust manufacturing processes. Design, establish, and optimize production lines for new and existing analytical instruments. Develop and implement product packaging solutions to ensure protection, compliance, and efficient logistics. Lead the qualification and validation of manufacturing processes to meet regulatory and quality standards. Plan, coordinate, and support product builds, from prototyping through to full-scale production. Monitor and drive improvements in production yield, efficiency, and product quality. Identify and implement continuous improvements in products and processes for enhanced quality, reduced cost, and improved delivery performance. Requirements Qualifications Requirements ~2+ years of relevant experience in manufacturing engineering, preferably in the instrumentation or high-tech equipment sector. Strong problem-solving skills with a hands-on approach to engineering challenges. Familiar with ISO9001 QMS Experience with production line setup, process qualification, and continuous improvement tools (e.g., Lean, Six Sigma) is a plus. Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams. Preferred Skills: Familiar with ISO13485 or 21CFR820 Quality Management System for Medical Device Prior design or development experience for analytical instruments or medical devices. Hands-on experience in prototyping, soldering, and debugging Education, License, Certification, or Preferred Qualifications Bachelor’s degree in Engineering or a related STEM discipline (e.g., Mechanical, Electrical, Industrial, or Manufacturing Engineering). Tools and Technology Used Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook…) Work Environment & Mental and Physical Requirements Ability to remain in a stationary position; move; operate and use required equipment; and reach items. Ability to move/transport up to 30 lbs., and up to 50 lbs. occasionally. Ability to communicate, converse with others, and exchange information Benefits Medical (HMO + PPO), Dental, Vision, & employer-paid Basic Life/AD&D + ST Disability 4% Match 401k PTO: 15 days (vacation/personal days) + 5 sick days + holidays
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