Apply on Employer Site

Pfizer · 1 month ago

Technical Operations Engineer IV

United States - North Carolina - Rocky Mount

Full-time

Onsite

Mid, Senior Level

$96K/yr - $160K/yr

4+ years exp

Pfizer is a leading pharmaceutical company committed to delivering safe and effective products to patients. The Technical Operations Engineer IV will serve as a subject matter expert in Computer System Validation, ensuring compliance and reliability in a dynamic manufacturing environment while leading projects and guiding technical teams.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

S/he acts as the SME for CSV work for Utilities, Facilities, Equipment and infrastructure related computer systems across the site

S/he organizes, oversees and analyzes testing associated with the development of new process technologies and the support of new systems introductions

S/he will be expected to ensure site alignment to global procedures and work instructions related to CSV

S/he will be expected to confirm validation pre-requisites are met and supported by approved documentation in accordance with procedures and industry standards

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

Qualification

Computer System ValidationPharmaceutical RegulationsProject ManagementData Integrity ComplianceTechnical WritingRisk ManagementLeadership SkillsInterpersonal SkillsProblem-Solving

Required

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 technical knowledge, is required to work with multi-disciplinary teams

Must be self-motivated and work with minimum direction

Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments

An aptitude for understanding process technology and controls applications, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with all levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities

Demonstrated understanding of global regulations on data integrity, GAMP guidelines, general GMP/GxP, and FDA 21 CFR Part 11 requirements

Must understand basic manufacturing processes and data recorded both electronically and on paper records

Preferred

Technical writing experience

Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices

Working knowledge of Food and Drug Administration (FDA) Regulations/Guidance, and Good Manufacturing Practices (GMP)

Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results

Strong background in problem-solving, negotiations, and data integrity principles

Experience in project management/support within a matrixed reporting environment

Good understanding of risk management methodologies and their application to Bio-pharmaceutical operations