System Specialist

Scorpion Therapeutics; Andover (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Pfizer is seeking a System Specialist to support instrumentation lifecycle activities within cGMP Quality Control and Manufacturing at the Andover site. You will ensure instrument integrity, perform troubleshooting, and collaborate with QC Lab and Manufacturing teams to maintain compliant systems.

The role requires a bachelor's degree with 2+ years of experience in regulated hardware/software, strong documentation skills, and the ability to handle periodic off-hours support as needed.

Qualifications

• Bachelor's degree or equivalent with at least 2 years of experience in regulated hardware/software support.
• Experience supporting instrument lifecycle processes in cGMP environments.
• Strong troubleshooting, project management, and documentation skills.

Responsibilities

• Provide technical support for hardware/software installation, troubleshooting, validation, upgrades, and decommissioning of lab and manufacturing instruments.
• Author/review validation and maintenance documentation.
• Support system qualification, integrity, and performance projects.
• Contribute to continuous improvement initiatives.

Skills

Troubleshooting

Project management

Documentation

Education

Bachelor's degree or equivalent

Tools

Regulated hardware/software

Job description

Role

System Specialist supporting instrumentation lifecycle activities within cGMP Quality Control and Manufacturing at Pfizer's Andover site.

Responsibilities

• provide technical support for hardware/software installation, troubleshooting, validation, upgrades, and decommissioning of lab and manufacturing instruments.
• author/review validation and maintenance documentation.
• support system qualification, integrity, and performance projects.
• and contribute to continuous improvement initiatives.

Requirements

• bachelor's degree with at least 2 years' experience, or equivalent combination.
• experience supporting regulated hardware/software and instrument lifecycle processes.
• strong troubleshooting, project management, and documentation skills.

Preferred

• experience validating and decommissioning QC/mfg instruments.
• knowledge of cGMP, Data Integrity, 21 CFR Part 11, ICH guidelines.
• familiarity with network technologies, virtualization, and Windows troubleshooting.

High-Value

• cGMP environment
• QC/mfg instruments
• validation/qualification
• instrument lifecycle management
• cross-functional support
• first shift onsite
• occasional off-hours support

Collaboration

work closely with Site Technical Services, QC Lab, and Manufacturing teams.

Worksetup

on-premise in Andover, Massachusetts.