Technical Operations Engineer IV

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.

As part of this role, the lead Engineer is expected to serve as SME for site Computer System Validation for a dynamic, 24/7 manufacturing operation. Resource to provide guidance to site technical teams for managing computer system projects to ensure compliance, reliability and functionality.  Help in preparing forecasts for resources for assigned projects.  Support as an individual contributor and/or providing leadership of a team of junior team members/contractor resources through CSV activities.  You will contribute your comprehensive knowledge of principles, concepts/theories of the CSV discipline towards advancing new concepts/strategies and methodologies.  Individual to work as a technical SME/leader to facilitate agreement among cross functional team members.  

Ensures all project documentation is generated per the schedule, executed on time and that it is complete and accurate. Supports Data Integrity (DI)initiatives and maintenance of DI compliance associated with manufacturing processes and controls.

What You Will Achieve

In this role:

• S/he acts as the SME for CSV work for Utilities, Facilities, Equipment and infrastructure related computer systems across the site. Individual must have project management skills, knowledge and application experience of technical design reviews, commissioning and validation for pharmaceutical computer applications.  Individual will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation. S/he must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
•  S/he organizes, oversees and analyzes testing associated with the development of new process technologies and the support of new systems introductions. S/he works closely with site and global DI, Quality and Engineering resources to ensure appropriate validation of site systems is achieved and maintained against procedures and industry guidance. S/he plans, reviews and approves site technical reports, to include validation plans/protocols, design specs, Risk Assessments.
• S/he will be expected to ensure site alignment to global procedures and work instructions related to CSV. Development and maintenance of site documents related to CSV. Provide ongoing training, guidance and templates to support the technical teams within the Focus Factories.
• S/he will be expected to confirm validation pre-requisites are met and supported by approved documentation in accordance with procedures and industry standards. Oversee and assist team members and contractor resources with their assigned projects. Develop and design validation strategies, studies, draft and/or review project validation plans and documentation. Participate, present and defend data including but not limited to regulatory agencies. customer. corporate or internal requests.
• S/he to provide input in technology transfer, risk assessments, validation deviations and/or quality deviation investigations to identify root causes and define correction and/or preventive actions (CAPA). Author and/or review risk assessment documents that support Computer Systems.  Review and approve investigations, commitments, procedures, batch records as they relate to CSV applications. Provide technical input and complete SME impact assessment to proposed change controls vetted for implementation.  Participate in teams assembled to complete change control implementation for new computer systems introduced to the facility.

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. 
• Solid knowledge/understanding of CSV strategies.
• Understanding of various computer systems/applications related to pharmaceutical equipment, utility and facility systems.
• Strong leadership, organizational planning and project management skills, in addition to