Lead Lyophilization Process Engineer – GMP Pharma (Remote)

Initial Therapeutics, Inc.

Bedford (MA)

Hybrid

USD 100,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Flexible paid time off
Annual incentive plan
Career development opportunities

Job summary

Initial Therapeutics, Inc. is seeking a Senior Process Engineer in Bedford, Massachusetts. This role requires 10+ years of experience with lyophilization systems and will lead design, installation, and operational readiness activities for pharmaceutical manufacturing.

The ideal candidate will have extensive experience in aseptic processing, strong technical leadership skills, and a commitment to GMP compliance.

You will collaborate closely with engineering and manufacturing teams to successfully deliver projects while ensuring regulatory requirements are met.

Qualifications

  • 10+ years of experience in process engineering and pharmaceutical manufacturing.
  • Strong background in lyophilization systems supporting sterile vial manufacturing.
  • Experience with equipment qualification and startup processes.

Responsibilities

  • Lead design, installation, and operational readiness of pharmaceutical lyophilization systems.
  • Provide technical oversight during commissioning and qualification activities.
  • Collaborate with cross-functional teams to ensure compliance and delivery.

Skills

Process engineering
GMP compliance
Lyophilization systems
Aseptic processing
Automation systems
Project management

Education

BS/MS in Chemical Engineering

Tools

SCADA
PLC

Job description

Initial Therapeutics, Inc. is seeking a Senior Process Engineer in Bedford, Massachusetts. This role requires 10+ years of experience with lyophilization systems and will lead design, installation, and operational readiness activities for pharmaceutical manufacturing.

The ideal candidate will have extensive experience in aseptic processing, strong technical leadership skills, and a commitment to GMP compliance.

You will collaborate closely with engineering and manufacturing teams to successfully deliver projects while ensuring regulatory requirements are met.

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