Manufacturing Engineer II

$84,000 - $105,000/Yr

Akoya Biosciences - Marlborough, MA

Full-time - Entry Level

Marlborough, MA

Professional, Scientific, and Technical Services

About the position

The position at Akoya Biosciences involves providing technical support for reagent manufacturing processes within a Life Sciences Research environment. The role focuses on developing and improving manufacturing processes, ensuring compliance with industry standards, and supporting new product introductions. It requires collaboration with various teams to enhance product quality and efficiency while maintaining adherence to regulatory requirements.

Responsibilities

• Develop and maintain specifications, work instructions, process travelers, and Device History Records (DHR) for compliance within Akoya ISO13485/21 CFR 620 environment using Arena Product Lifecycle Management (PLM)
• Provide technical support and failure analysis for on-market products
• Develop manufacturing processes based on product requirements
• Develop/Improve testing and quality control measures for reagents
• Create process control methods to monitor and improve processes for quality and efficiency
• Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout
• Establish and perform process verification and process validations
• Support new product introduction activities
• Train technicians on new processes as needed to support manufacturing
• Support quality system compliance including material dispositions, change order implementation, and nonconforming evaluations
• Other duties as assigned

Requirements

• Bachelor's Degree in Biochemistry, Chemistry, Chemical/Biomedical Engineering or equivalent education/experience
• 2-5 years' experience in a Manufacturing operations environment; Biologic and/or chemical conjugations preferred
• Experience with HPLC, FPLC, and/or Mass Spec preferred
• Experience with GMP- or ISO-certified operations preferred
• Experience with Lean Manufacturing and Continuous Improvement preferred
• Excellent communication skills
• Ability to work well under pressure
• Strong working knowledge of MS Office
• Strong technical problem-solving skills

Nice-to-haves

• Experience with HPLC, FPLC, and/or Mass Spec
• Experience with GMP- or ISO-certified operations
• Experience with Lean Manufacturing and Continuous Improvement

Benefits

• Medical and Dental plans
• Life, AD&D and Short-Term Disability insurance
• Tuition Reimbursement
• 401(k) with immediate Company match vesting
• Company paid holidays
• Annual performance-based bonus
• Long-term incentive units (equity)