System Specialist

Pfizer; Andover (MA); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) matching

Pfizer retirement contribution

Paid vacation and leave

Health benefits

Job summary

Pfizer seeks a System Specialist at the Andover site to support Quality Control and Manufacturing Instrumentation lifecycle activities, including qualification, maintenance, troubleshooting, and data integrity within GMP environments.

You will contribute to validation/upgrade projects and generate documentation while collaborating with QC and GMP teams, with a Monday–Friday first shift and on-site work in Andover, MA.

Qualifications

• Bachelor’s degree with 2+ years in regulated environment.
• Experience supporting software/hardware/computer systems in a regulated setting.
• Knowledge of instrument lifecycle processes and data integrity requirements.

Responsibilities

• Support hardware/software installation, configuration, maintenance, troubleshooting, IQ/OQ/PQ support, and data virtualization.
• Provide project management and technical support across instrumentation processes and lifecycle activities.
• Resolve moderately complex instrumentation issues and contribute to related projects with QC/GMP teams.
• Support validation/qualification/upgrade, operation, maintenance, administration, and decommissioning projects at the Andover site.
• Author/review instrument documentation including validation, SOPs, system administration, and data reconciliations.

Skills

Instrumentation lifecycle

Troubleshooting

Project management

Data integrity

System administration

Network technologies

Virtualization

Windows OS

Education

Bachelor's degree + 2+ years

Master's degree + 0+ years

Associate's degree + 6 years

High school diploma + 8 years

Tools

Windows OS

Virtualization

SQL

Job description

Use Your Power for Purpose The 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 System Specialist will utilize their knowledge to provide technical support throughout the instrument lifecycle 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 and deliverables for cGMP instruments and workstations used in the Quality Control Laboratories and GMP manufacturing suites. The System Specialist will also 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:

• Support the Quality Control and Manufacturing Instrumentation Lifecycle Program and provide hardware and software installation, configuration, maintenance, and troubleshooting support, vendor and IQ/OQ/PQ support, 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
• Provide project management and technical support across instrumentation processes / programs, troubleshooting, and lifecycle activities and reliability / performance issue resolution actions
• Make decisions to resolve moderately complex instrumentation issues and contribute to moderately complex instrumentation projects in collaboration with Quality Control and/or GMP Manufacturing Team(s)
• Support validation / qualification / upgrade, operation, maintenance, system administration, reliability and/or decommissioning projects at the Andover site
• 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

Work under general supervision, using own judgment where needed / appropriate

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience Experience supporting software / hardware / computer systems and instrument lifecycle processes in a regulated environment

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 $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary.

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.

Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Engineering Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.