Aseptic Process Engineering Manager

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan

Job summary

Simtra BioPharma Solutions is seeking a Process Engineering Manager in Bloomington, Indiana. You will lead a team of engineers and technicians to ensure aseptic processing, filling and packaging activities meet timelines and budgets.

You will report to the Director of Engineering and drive Lean initiatives, validation activities, and change control across the department to support compliant, on-time delivery.

Qualifications

• Bachelor degree in Engineering required.
• Advanced degree preferred.
• Minimum 10 years of experience in aseptic manufacturing.
• Minimum 5 years supervisory experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook; ability to use enterprise software.

Responsibilities

• Provides guidance, support, direction and leadership through daily operations (24/7).
• Interviews, hires, coaches, and develops staff; conducts annual performance reviews.
• Manages a team of engineering professionals to support aseptic processing, filling and packaging equipment processes.
• Oversee departmental capital equipment budgets, VI Projects, and optimization.
• Ensures department compliance for master change control and validation protocols.
• Utilize Lean principles to manage tasks within quality, time, safety and budget.
• Manages project timelines for equipment design specs, procurement, DOE, FAT, installation, validation, SOPs and transfers.
• Provides guidance on design and technical direction to engineering staff.
• Reviews and approves WOs, change controls, reports, validation protocols, expense approvals.

Skills

Aseptic manufacturing

Engineering leadership

Supervisory experience

Microsoft Office

ERP software

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions is seeking a Process Engineering Manager in Bloomington, Indiana. You will lead a team of engineers and technicians to ensure aseptic processing, filling and packaging activities meet timelines and budgets.

You will report to the Director of Engineering and drive Lean initiatives, validation activities, and change control across the department to support compliant, on-time delivery.