As a Validation Engineer you will be responsible for validating/qualifying the systems, equipment, utilities used to manufacture and/or clean drug products within a clinical manufacturing facility located in Groton, CT. As part of new technology Implementation, you will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. You will assist with front line trouble shooting of equipment related issues. Additionally, you will work with Global Operations (GO) Quality (QA) Analytical Research and Development (ARD) and Pfizer Global Sourcing (PGS) to support the manufacture of oral dosage form clinical supplies and solid dose process development activities.
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, protocol execution, data review and final report generation.
Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.
Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Supports cleaning program through swabbing and visual inspection and equipment evaluation.
Understanding of facility design and associated building management systems.
Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of pharmaceutical manufacturing equipment and associated services.
Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Proven ability to deliver technical reports and presentations.
Other duties include, but are not limited to:
Provide support for additional focus area: Automation, Facility Support, Capital Projects
Assist in ensuring future equipment meet the technical requirements of the operation, wet granulation equipment for example.
Contribute to 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.
Support and develop equipment/services robustness and manage the risks and impact of failure.
Manage minor 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.
Experience implementing changes/upgrades and troubleshooting of computerized operating systems through an understanding of network infrastructure and automation solutions. Including:
HMIs (Human Machine Interfaces)
PLCs (Programable Logic Controllers)
IDCs (Industrial Data Centers)
VMs (Virtual Machines)
Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
Some knowledge and experience with equipment, facility, utility or computer system validation, as related to sterile products and medical devices preferred
Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
Must be able to interact with varying levels within the company
Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
Strong conflict resolution skills
A detailed knowledge of GMP and management of quality through quality systems.
Role requires a Groton site presence.
The job requires to operate pieces of manufacturing equipment in the Groton SDM area and requires business trips for FATs as well as business meetings (may require international travel).
Standing, walking, bending, climbing, reaching and lifting upward of 55 pounds may be required. Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to work some evenings and weekends as needed to meet deadlines or support manufacturing
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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.