Validation Engineer - Laboratory Instruments

ROLE SUMMARY
The position of Validation Engineer - Laboratory Instruments is an individual contributor role which, under the guidance of a more senior Engineer or Manager, is responsible for the validation lifecycle of laboratory instruments within the Quality Laboratories at the Pfizer, Inc. sterile injectable manufacturing facility located in Rocky Mount, North Carolina, USA.

ROLE RESPONSIBILITIES

• Serving as validation representative for laboratory instruments and partnering with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site.
• Performs periodic review of instrumentation and associated computer systems a needed.
• Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to, or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories.
• Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.
• Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps.
• Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans.
• Completes periodic reviews of laboratory instruments and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument.
• All other duties as assigned.

BASIC QUALIFICATIONS

• Bachelor's degree in science, engineering, manufacturing technology or closely related field required.
• 2 years of experience in validation of instruments including those with computerized systems (e.g. AA, DNA Sequencer, FT-IR, IC, ICP-MS, Particle Counter, TOC, UV_Vis) in a cGMP environment required.
• Excellent attention to detail and knowledgeable of FDA Regulations/Guidance, and Good Manufacturing Practices.
• Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.
• Ability to manage multiple activities and constantly change priorities.
• Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments within various areas (Biological, Chemical, Environmental Monitoring, Micro, etc.).
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
• Proven ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.
• Good communication skills, oral and written, and attention to detail.
• Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).

PREFERRED QUALIFICATIONS

• Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
• 1+ years' experience in performing periodic review of laboratory instruments including those with computerized systems.
• Experience with Trackwise CR/PR/CAPA systems.
• Strong critical thinking and problem solving skills.

PHYSICAL/MENTAL REQUIREMENTS

• Mathematical and scientific reasoning ability.
• Occasionally lift a computer system and/or instrument up to 50 pounds.
• Use a computer terminal for up to 8 hours per shift, work around moving equipment, work with chemical and biological materials.
• Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Primary work schedule is Day shift, Monday - Friday but evenings, weekends and holidays will be required, as needed to support laboratory processes at the Rocky Mount site.
• Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.
• Work safely in laboratory areas where biological and chemical hazards are present.

Other Job Details:

• Last Date to Apply for Job: 15 NOVEMBER 2020
• Eligible for Employee Referral Bonus
• #LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Engineering