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Quality Engineer, Laboratory Instrument Validation

Pfizer


Location:
Rocky Mount, NC
Date:
11/16/2017
2017-11-162018-01-06
Pfizer
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Job Details

**ROLE SUMMARY**



The **Quality Engineer III - Instrument Validation** will be responsible for:







+ Serving as validation representative for instruments



+ Partnering with the laboratories, quality system administrators, BT, instrumentation and quality on implementing new instruments at the site



+ Performing the following:







+ analytical instrument validation including computerized system validation if applicable



+ spreadsheet validation



+ any validation change control during the life-cycle of the system



+ system periodic review



+ system decommissioning



+ This position will be responsible for providing end-user support for all Quality Laboratory groups as well as compliance to global and site internal policies and procedures.







**ROLE RESPONSIBILITIES**







+ Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories.



+ Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs.



+ Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.



+ 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.



+ Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.



+ Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument. Previous experience with PR/CAPA systems preferred.



+ Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.



+ All other duties as assigned.







**QUALIFICATIONS**







+ Bachelor's degree in a science or engineering related discipline with knowledge in quality operations laboratory processes.



+ 5-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment **(required)** .



+ 3-5 years of experience in the Pharmaceutical industry or relevant business experience.



+ Hands on experience operating instrument systems.



+ Excellent communication skills, oral and written, and attention to detail.



+ Must be able to work independently.



+ Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).



+ Good understanding of with global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.



+ Demonstrated ability to work in a team environment and manage workload to meet deadlines.



+ Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.







**PHYSICAL/MENTAL REQUIREMENTS**







+ Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 pounds per activity 4 times per shift, work around moving equipment, work with biological materials.



+ Occasionally lift a computer system and/or instrument up to 50 pounds.



+ 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.



+ Mathematical and scientific reasoning ability.







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**







+ May be required to work non-standard hours including weekends and holidays to support laboratory processes at the Rocky Mount site.



+ Some gowning may be required to enter laboratory areas.



+ Work safely in laboratory areas where biological and chemical hazards are present.







**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.







**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.







**Additional Offer Details:**







+ **Last Date to Apply for Job: 15 December 2017**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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