Senior Validation Engineer - Laboratory Instruments
Company: Pfizer
Location: Rocky Mount
Posted on: May 14, 2022
Job Description:
ROLE SUMMARYThe position of Senior Validation Engineer -
Laboratory Instruments is an individual contributor role which,
under the guidance of the 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
softwarewhere 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 softwarewith focus on change control,
deviation investigations and CAPA to ensure compliance and
validated state of the instrument.
- Reviews validation deliverables created by others for adherence
to site validation SOPs and acts as validation approver as
needed.
- Supports client and regulatory audits.
- May supervise and/or mentor junior level engineers.
- All other duties as assigned.BASIC QUALIFICATIONS
- Bachelor's degree in science, engineering, manufacturing
technology or closely related field.
- 3-5 years' 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.
- Excellent attention to detail and working knowledge 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.
- Excellent communication skills, oral and written, and attention
to detail.
- Mastery of core computer software/systems (Word, Excel,
Sharepoint, etc.).PREFERRED QUALIFICATIONS
- Bachelor's degree in a science or engineering related
discipline with knowledge of quality operations laboratory
processes.
- 5+ years' experience in the validation of laboratory
instruments including those with computerized systems (e.g. AA, DNA
Sequencer, FT-IR, IC, ICP-MS, Particle Counter, TOC, UV_Vis) in a
biotechnology or pharmaceutical cGMP manufacturing
environment.
- 3+ years' experience in performing periodic review of
laboratory instruments including those with computerized
systems.
- Demonstrated expertise in identifying as well as formulating
procedural controls to compensate for shortcomings in the system's
data integrity and FDA 21 CFR Part 11 controls.
- Experience with TrackWise CR/PR/CAPA systems.
- Lean Sigma Greenbelt Certification.
- 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 biological and chemical
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.
- Minimal travel may be required.Other Job Details:
- Eligible for Employee Referral Bonus
- Pfizer requires all U.S. new hires to be fully vaccinated for
COVID-19 prior to the first date of employment. As required by
applicable law, Pfizer will consider requests for Reasonable
Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Quality Assurance and Control
Keywords: Pfizer, Rocky Mount , Senior Validation Engineer - Laboratory Instruments, Engineering , Rocky Mount, North Carolina
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