Computer System Specialist - Andover, MA

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.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

Additional Qualifications / Responsibilities

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

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.

Salary : $30,000 - $133,000