Senior System Specialist

Scorpion Therapeutics; Andover (MA); On-site; USD 110,000 - 145,000; Full time

Job summary

Pfizer in Andover, MA is seeking a Senior System Specialist to support instrumentation lifecycle management for quality control and GMP manufacturing instruments. You will install, qualify, upgrade, operate, troubleshoot, and decommission cGMP instruments; lead validation and system administration initiatives; and author validation documentation.

Candidates should have a bachelor's degree with 4+ years in regulated environments and strong knowledge of hardware, software, networks, and cGMP

Qualifications

• Experience supporting instrument systems in regulated environments.
• Strong troubleshooting across hardware, software, and networks.
• Familiarity with cGMP, data integrity, and 21 CFR Part 11 requirements.

Responsibilities

• Install, qualify, upgrade, operate, troubleshoot, and decommission cGMP instruments.
• Lead validation, system administration, and continuous improvement projects.
• Author and review validation and system documentation.
• Collaborate withvendors and internal teams to ensure regulatory compliance.

Skills

Instrument systems experience

cGMP troubleshooting

Hardware troubleshooting

Network technologies

Education

Bachelor's degree or equivalent in a related field

Job description

Role:

Senior System Specialist supporting instrumentation lifecycle management at Pfizer's Andover site, focusing on Quality Control and GMP manufacturing instruments.

Responsibilities:

• provide technical support for hardware/software installation, qualification, upgrades, operation, troubleshooting, reliability, and decommissioning of cGMP instruments
• lead validation, system administration, and continuous improvement projects
• author and review validation and system documentation
• collaborate with vendors and internal teams to ensure compliance with cGMP, Data Integrity, and 21 CFR Part 11 standards

Requirements:

• bachelor's degree with ≥4 years experience, or equivalent, supporting instrument systems in regulated environments
• proficient in hardware, software, network technologies, and troubleshooting in cGMP settings

Preferred:

• experience validating and decommissioning QC/manufacturing instruments
• knowledge of network security, virtualization, and regulatory standards

High-Value:

emphasis on instrument lifecycle, cGMP compliance, validation, and system troubleshooting in a pharmaceutical manufacturing setting.

Work setup:

on-premise, first shift, with occasional off-hour support and some travel.