Senior System Specialist

Pfizer; Andover (MA); On-site; USD 99,000 - 165,000; Full time

Benefits offered by this job

401(k) with Pfizer matching

Paid vacation

Health benefits

Job summary

Pfizer in Andover, MA is seeking a Senior System Specialist to support instrument lifecycle activities across Quality Control and GMP manufacturing suites. The role includes hardware/software installation, troubleshooting, and data integrity tasks within a regulated environment.

You will lead project management, validation/upgrade efforts, and documentation development while collaborating with QC and GMP teams to ensure reliability and compliant operations.

Qualifications

• Bachelor's degree with 4+ years experience in a regulated environment.
• Master's degree with 2+ years experience or PhD with 0+ years experience.
• Associate's degree with 8 years experience or a high school diploma with 10 years experience.

Responsibilities

• Support instrument lifecycle processes across Quality Control and Manufacturing instrumentation.
• Lead projects, validation/qualification/upgrade activities.
• Prepare and review validation and instrument documentation, Change Controls and investigations.
• Provide incident response, data integrity assessments, and decommissioning support.

Skills

Instrumentation lifecycle experience

Regulated environment experience

Project management

Education

Bachelor's degree with 4+ years experience

Master's degree with 2+ years experience

PhD with 0+ years experience

Associate's degree with 8 years experience

High school diploma with 10 years experience

Tools

IQ/OQ/PQ

Virtual Network (VLAN)

Network security protocols

virtualization systems

Windows operating system troubleshooting

Job description

Use Your Power for Purpose The Senior System Specialist under Andover Site Technical Services (STS) Instrument Services (IS) provides technical support across instrumentation lifecycle activities in support of the Quality Control and Manufacturing Instrumentation Program at the Andover, Massachusetts site. The Senior System Specialist will utilize their Subject Matter Expertise to provide technical support throughout the instrument lifecycle, drive instrument lifecycle project work, deliverables, and documentation, and support instrument qualification / upgrade, operation and maintenance programs, troubleshooting, performance issue resolution, reliability, periodic review / System Health Check, electronic data reconciliation, administrative, and decommissioning actions for cGMP instruments and workstations used in the Quality Control Laboratories and GMP manufacturing suites. The Senior System Specialist will also lead and support technical and Continuous Improvement projects across the Site Technical Services, Quality Control Laboratory, and GMP Manufacturing team(s).

What You Will Achieve In this role, you will: Contribute to the Quality Control and Manufacturing Instrumentation Lifecycle Program and provide hardware and software installation, configuration, maintenance, and troubleshooting support and guidance, vendor and IQ/OQ/PQ support and input, new system set-up, back‑up, and restoration support, kiosk mode software and Global Data Protection Solution installation, activation, and troubleshooting support, and data virtualization support Lead and provide project management and technical support across instrumentation processes / programs, troubleshooting, and lifecycle activities and reliability / performance issue resolution actions Lead and guide the resolution of moderate to high impact, complex instrumentation issues and projects in collaboration with Quality Control and/or GMP Manufacturing Team(s) Lead and support validation / qualification / upgrade, operation, maintenance, system administration, reliability and/or decommissioning projects at the Andover site and supports network teams / initiatives Author and/or review routine to complex instrument documentation including (but not limited to) validation documentation, operation and maintenance procedures, system administration procedures, instrument periodic review / System Health Check, data integrity assessments, electronic record assessments, electronic data reconciliations, decommissioning documentation, Change Controls, investigations, and/or Corrective and Preventative Actions Exercise own judgement, works independently, and provides guidance to lower-level team members.

Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience Experience supporting software / hardware / computer systems and instrument lifecycle processes in a regulated environment Bonus Points If You Have (Preferred Requirements) Experience validating, maintaining, and/or decommissioning quality control or manufacturing instruments Knowledge and practical application of relevant cGMP principles and industry standards as they pertain to instrument lifecycle and Data Integrity and ERES requirements (21 CFR Part 11, ICH, Annex 11) Proficiency with Network Technologies such as Virtual Network (VLAN), Network Security Protocols, and firewall technologies, familiarity with server components/configuration and virtualization systems, and experience troubleshooting Microsoft Operating System and components such as windows registry and system files PHYSICAL/MENTAL REQUIREMENTS Ability to perform mathematical calculations, scientific computation, complex data analysis, verbal communication, written communication, strategic thinking, business acumen, project management. Normal lifting, sitting, standing, and walking requirements to facilitate support of team in the office and in the laboratories / manufacturing areas. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Position is first shift Monday through Friday Occasional off-hour support to address time-sensitive production and business-related issues Work Location Assignment: On Premise The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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