Computer System Specialist

Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action
What You Will Achieve
The Computer System Specialist will provide support for computer workstations associated with a diverse variety of Quality Control and Manufacturing instrumentation, including analytical and microbiological instruments, throughout their system lifecycles. Primary responsibilities include application configuration, troubleshooting, NuGenesis protocol execution, support of instrument validation activities / deliverables, ensuring data integrity compliance, and administrative activities such as account management, date and time updates, and database backups.
In this role you will also provide technical support for troubleshooting actions, instrument lifecycle / validation activities, and technical and Continuous Improvement projects across Site Technical Services, Quality Control Laboratory, and Andover Production Operations teams.
How You Will Achieve It

• Plan, coordinate, and support the implementation of new applications and software upgrades
• Participate in the validation of instrumentation (activities such as NuGenesis Protocol execution and support of validation deliverables / documentation) and computer systems
• Troubleshoot software / application issues and connectivity and reliability issues related to instrument systems
• Support the User Account Management program, assigning user accounts to analysts as required
• Ensures Data Integrity (DI) compliance for all GMP computer systems used with Quality Control and Manufacturing instrumentation and perform DI and Electronic Record Electronic Signature (ERES) assessments for computer workstations
• Create virtual environments to support Data Restore testing functionalities during System Annual Periodic Reviews
• Provide troubleshooting support and technical direction across systems, implementation of projects, CAPAs, investigations, and decommissioning projects
• Support the instrument validation program and procedures in compliance with corporate, regulatory, and industry standards and regulations
• Plan and coordinate validation / qualification deliverables and actions with applicable end user
• Support instrument maintenance programs as applicable
• Support electronic data reconciliation actions, as applicable
• Exercises judgment in supporting resolution of moderate to high impact/complex instrument issues
• Leverage site project management and change management procedures to author and revise quality documents and SOPs, support Change Control implementation, commitment action item implementation, and support investigation / deviation resolution
• Maintain cGMP compliance inspection readiness in regard to instrumentation, computer systems, and DI
• Provide operational technical support for Quality Control and Manufacturing computers supporting instrument systems in Production and Validation environments
• Creates and fosters collaborative customer relationships and regularly provides guidance regarding quality improvements to stakeholders
• Support the instrument program and procedural changes that enhance safety, compliance, and overall operational efficiency
• Collaborate with colleagues and site functional areas to drive department, quality, and site goals and objectives
• Support a continuous improvement culture across instrumentation processes
• Work with vendors and have excellent customer service skills

Qualifications
Must-Have

• 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 in software / computer system support in regulated environment
• Experienced with Data Integrity and ERES requirements (21 CFR Part 11, ICH, Annex 11)
• Knowledge and practical application of relevant cGMP principles as they pertain to instrument lifecycle and system administration
• Proficient with Network Technologies such as Virtual Network (VLAN), Network Security Protocols and firewall technologies
• Proficient at troubleshooting Microsoft Operating System and components such as windows registry and system files
• Familiarity with server components/configuration
• Familiarization with virtualization systems such as VMware and Microsoft Hyper-V
• Team player mindset and excellent customer service skills.

Nice-to-Have

• Knowledge of computer system hardware, infrastructure and networks
• Background in problem solving, negotiations, and project management/support in a matrixed reporting environment
• Change Control or Project Management experience
• Understanding of continuous improvement tools and skills (standard work, visual management, DMAIC)

Physical/Mental Requirements

• Position requirements are typical for an office-based work environment with some lab and manufacturing floor exposure.
• Self-motivated with the ability to adapt to rapidly changing project priorities and work collaboratively on a cross-functional team
• Ability to communicate effectively with site leadership, stakeholders, end users, etc.

Non-Standard Work Schedule, Travel, or Environment Requirements

• Schedule is primarily day shift (M-F, 8 hrs) but may require off-shift work on occasions.
• No travel required

Other Job Details:

• Last day to Apply: February 14th , 2025
• Eligible for Relocation Assistance: NO
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $80 300,00 to $133 900,00. 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.
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.
Engineering