Manager, Process Engineering

Simtra BioPharma Solutions

$110K — $130K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering required
  • Advanced degree preferred
  • 10+ years of experience in aseptic manufacturing
  • 5+ years of supervisory experience
  • Proficiency in Microsoft Office and enterprise software

Responsibilities

  • Provide leadership and support for daily operations 24/7
  • Conduct interviews, hiring, coaching, and performance reviews for staff
  • Manage engineering team supporting aseptic processing and equipment
  • Oversee departmental budgets and optimization projects
  • Ensure compliance with master change control and validation protocols
  • Apply Lean principles to complete departmental tasks efficiently
  • Manage timelines for project specifications, procurement, testing, and transfer processes

Benefits

  • Comprehensive medical and dental coverage
  • 401(k) plan with company match
  • Generous paid time off and parental leave
  • Education assistance for professional development
  • Onsite amenities including a workout facility and cafeteria
Full Job Description
This Role:

The Process Engineering Manager ensures projects, protocols and planned activities meet committed timelines and budgets to ensure compliance and on-time delivery. This position oversees a group of Engineering professionals and Technicians. This position reports to the Director, Engineering.

The Responsibilities:
  • Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations (24/7).
  • Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans
  • Manages a team of engineering professionals to support aseptic processing, filling and packaging equipment processes.,
  • Oversee departmental capital equipment budgets, Value Improvement Projects, and equipment/process optimization.
  • Ensures department compliance for master change control management and validation protocols.
  • Utilize Lean principles to manage the successful completion of departmental tasks within the boundaries of quality, time, safety and budget.
  • Responsible for overall management of project timelines associated with generating equipment design specifications, procurement, design of experiments, factory acceptance testing, installation, coordination of validation activities, standard operating procedure (SOP) generation, and transfer to functional area for in-service status.
  • Provides guidance on design and technical direction to engineering staff.
  • Provides review and approval of Engineering Work Orders, Master Change Controls, Exception Reports, Technical Summaries, Validation protocols, expense approvals and CAPA's.


Required Qualifications:
  • Bachelors degree in Engineering discipline 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 and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)


Physical / Safety Requirements:
  • Must be able to gown qualify for Grade A/B are
  • Must be able to lift up to 50lbs.
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting or standing for long hours.


In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

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