Process Engineer II - cGMP Process Optimization & Validation

SupportFinity™; United States; On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

401(k) plan with up to 5% company match

Employee stock purchase plan at a 15% discount

Comprehensive healthcare benefits

Accrued paid time off

Job summary

SupportFinity™ is looking for a Process Engineer II to enhance process improvement initiatives for medical devices and drug products. This role involves designing and implementing equipment that supports cGMP-compliant manufacturing while applying analytical skills to troubleshoot and optimize processes.

The ideal candidate should possess a Bachelor's degree in Engineering and have 2–5 years of experience in a cGMP-regulated environment. SupportFinity™ offers competitive benefits inclusive of healthcare, a 401(k) plan with a company match, and additional employee stock purchase options.

Qualifications

• 2–5 years of experience in a cGMP-regulated environment.
• Experience with medical device manufacturing or pharmaceutical processes preferred.
• Proficient with material, equipment, and process validation in the medical device and pharmaceutical industry.

Responsibilities

• Support the design and specification of equipment and systems in alignment with cGMP.
• Identify opportunities for cost reduction and process efficiency improvements.
• Collaborate with validation teams to ensure compliance with commissioning and qualification requirements.

Skills

Strong equipment and process troubleshooting skills

Good communication skills (written and verbal)

Understanding of FDA, ISO 13485, and EU MDR compliance

Proficient with statistical analysis techniques and software

Experience with processes such as formulation and filling for viscous solutions

Experience with automation platforms such as Rockwell Automation

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field

Tools

Microsoft Project

ERP systems

MES systems

Job description

SupportFinity™ is looking for a Process Engineer II to enhance process improvement initiatives for medical devices and drug products. This role involves designing and implementing equipment that supports cGMP-compliant manufacturing while applying analytical skills to troubleshoot and optimize processes.

The ideal candidate should possess a Bachelor's degree in Engineering and have 2–5 years of experience in a cGMP-regulated environment. SupportFinity™ offers competitive benefits inclusive of healthcare, a 401(k) plan with a company match, and additional employee stock purchase options.