Job Description

As a Senior Validation Engineer you will be accountable for validating/qualifying the systems, equipment and utilities used in the development and clinical manufacture of a range of solid dosage forms. This position will play a key role in leading the Qualification/Validation and providing on-going assistance for Advanced Manufacturing Drug Product Platforms including Pfizer Continuous Manufacturing Unit in Sandwich.

An individual contributor role that applies extensive Equipment and Utilities lifecycle management, technical knowledge, control system understanding and engineering knowledge to the design, qualification and cleaning of advanced manufacturing platforms (process equipment, Digital systems, and utilities) within the drug product manufacturing group in Sandwich. The role will also assist the safety and Cleaning Programs in the DPM.

You will help to design robust manufacturing solutions and demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

Colleague will work closely with operational and technical teams within department to validate equipment, utilities, systems and cleaning activities. Colleague will interact with Global Workplace Solutions, Quality Assurance, Digital Technology, and Environmental Health and Safety and global / project analytics to assist the manufacture of solid oral dosage forms for clinical supply.

Organisational Relationships:

Department: Drug Product Manufacturing Group, Drug Product Supply, Pharmaceutical Sciences Small Molecule (PSSM)

Reports to: Validation and Technical Support Lead - DPM

Liaises with: Key stakeholders in DPM, DPD, PGS, GWS, Quality, Safety PA, GA and external subject matter experts

Resources controlled: Role will typically operate as an individual contributor with significant mentorship of junior colleagues contributing to local department, global department, and cross line initiatives. Role will be a recognised SME in equipment, facility, system lifecycle and have knowledge of cleaning validation program.

Requirements:

• Should be educated to degree level in Mechanical, Bio Engineering, Biomedical Engineering or Chemical Engineering, alternatively extensive experience within the field of 10+ years of relevant Pharmaceutical experience will also be considered.
• Expert understanding of Good Manufacturing Practice and Quality Systems in R&D. Comprehensive knowledge of GMP and demonstrated understanding of compliance and quality management. Ability to independently author GMP documentation, Quality records and SOP\xe2\x80\x99s.
• A subject matter expert in the regulatory and validation requirements of new and existing manufacturing technology used in the clinical manufacture of Solid Oral Dosage forms.
• Subject matter expert with comprehensive technical knowledge in equipment, facility and utility asset lifecycle management from initial design and procurement through to qualification / validation and operational use including, Understanding of facility design and associated building management systems.
• Comprehensive knowledge of appropriate safe working practices for manufacture of oral dose products including DSEAR and ATEX.
• Working Knowledge of GAMP 5 regulations and digital lifecycle management.
• Comprehensive understanding of engineering operations including; instruments, controls and mechanical aspects of manufacturing equipment and associated services.
• Comprehensive technical knowledge in solid dose manufacturing, and advanced manufacturing technologies used in the clinical manufacture of conventional and complex solid dosage forms, including continuous manufacturing.
• Interprets internal/external business/regulatory challenges and best practices to recommend innovative technology solutions in the Equipment/Facility Lifecycle space.
• Able to determine compliance and efficiency improvements in the area of; Equipment, Validation, Facility validation, Cleaning Validation and Technical Support.
• Evidence of trouble shooting and problem solving of complex issues utilizing lean concepts and 6 sigma or equivalent tools.
• Ability to independently lead and be accountable for the work of matrix teams. Has the ability to make decisions which will have impact across global DPM group. Evidence of planning and organizational skills in the project management of operational projects.
• Knowledge of cleaning validation program, cleaning processes used in solid oral dose and cleaning regulations is highly desirable.

:

• Lead the initial qualification and validation of Continuous Manufacturing Module. Support on-going lifecycle needs.
• Provide Operational Assistance/Troubleshooting for Advanced manufacturing Technologies.
• Develop and implement Digital Lifecycle management approach for the group.
• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Executes validation activities to include Change Control initiation, protocol preparation, scheduling, Factory Acceptance Testing, protocol execution, data review and final report generation.
• Accountable for completion of fully system lifecycle activities associated with equipment, utilities or facilities from project initiation through to retirement / redesignation.
• Assist/lead development / improvements to the validation program as needed to remain current with cGMPs and industry standards.
• Assist and lead teams assembled to; specify, install, validate, troubleshoot and maintain systems and equipment.
• Assist/lead deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Assist/Lead presentation of data and strategy in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
• Assist the Cleaning Validation Program as needed. Provi
• Assist maintaining the compliance of all manufacturing equipment against the relevant procedures, PQS\xe2\x80\x99s and regulatory expectations.
• Assist the equipment automation and control strategy, software compliance and adherence to the necessary DI requirements.

• Supports DPM audit responsibility for equipment validation, facility validation and cleaning validation.
• Manages DPM external equipment vendor planning and execution, to successful release and operation of the equipment.
• Provides technical input to solid dose manufacturing processes and technology activities including, technical support to Global Workplace Solution (GWS) on equipment breakdown, facility modifications and appropriate planned preventative maintenance regimes.
• Supports strategic management of GWS interactions including technical support to equipment breakdown, review and implementation of planned maintenance strategies, risk assessment and publication of key performance metrics.
• Project management for the implementation of new processes working in partnership with other members of DPM to develop URS\xe2\x80\x99s for equipment and technology with a focus on Critical Process Parameters for product quality, safety and execution of risk based validation/verification approaches.
• Supports DPM major and minor capital budgets with subject matter expertise on process ordering system and purchasing management of ancillary items of equipment and associated documentation within team.
• Develops new ways of working and Drives global continuous improvement activities in the validation and technical support space for enhanced efficiency in delivery and maintenance of compliance including digitization of processes and systems to remove paper.

Other duties include, but are not limited to:

• Provide support for additional focus area: Automation, Facility Support, Process Development, Capital Projects
• Assist/lead ensuring future equipment meet the technical requirements of the operation.
• Lead or Co-Lead the selection and integration of new equipment and services, ensuring validation, quality requirements and the process capability of the equipment is in line with pre-defined needs.
• Develop equipment/services robustness and manage the risks and impact of failure.
• Manage major projects which include all operational and financial aspects. Drive quality, safety and continuous improvement related activities.
• Deliver training and support to ensure efficient use and deployment of equipment.
• Provide immediate troubleshooting and manufacturing support during manufacturing operations.

Work Location Assignment: On Premise

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