Senior Principal Validation Engineer - ABQ
Company: Curia
Location: Amityville
Posted on: March 20, 2023
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Job Description:
Summary:
The Validations Department is responsible for formulating,
reviewing, and approving all validation protocols related to
manufacturing and quality operations and providing guidance to
production and quality regarding equipment, component, process, and
system-related functions.
Responsible for computer-related system validations and assurance
of GxP compliance to 21 CFR parts 210, 211, and 820. Ensures change
controls, records, and procedures comply with current Good
Manufacturing Practices (cGMP) and meet applicable GAMP
requirements. Coordinates validations with section supervisors to
ensure timeliness with minimal disruption of production schedules.
Writes validation protocols, final reports, and summaries of work
for the release of equipment, systems, instruments, components, and
utilities tested.
Essential Duties and Responsibilities:
Supervisory Responsibilities:
None
Education and/or Experience:
B.S. in Computer Engineering or Physical Sciences (or equivalent)
with a minimum of twelve (12) years of directly applicable
experience. Must have experience in high-level mathematics (i.e.,
calculus) and technical writing. Knowledge of regulations FDA, ISO
9000-3, PIC/S guides to cGMP, GAMP4, and GAMP 5 based on GAMP
V-Model Framework, EUGMP Annex 11 "Computer Systems."
Language Skills:
Ability to read, analyze, and interpret general business
periodicals, professional journals, technical procedures, or
governmental regulations. Ability to write reports, business
correspondence, and procedure manuals. Ability to effectively
present information and respond to questions from groups of
managers, clients, customers, and the general public.
Mathematical Skills:
Ability to work with mathematical concepts such as probability and
statistical inference, and fundamentals of plane and solid geometry
and trigonometry. Ability to apply concepts such as fractions,
percentages, ratios, and proportions to practical situations. .
Ability to comprehend and apply principles of calculus, modern
algebra, and statistics. Ability to define problems, collect data,
establish facts, and draw valid conclusions from these
observations.
Reasoning Ability:
Ability to solve practical problems and deal with a variety of
concrete variables in situations where only limited standardization
exists. Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
Computer Skills:
To perform this job successfully, an individual should know
Database software; Internet software; Spreadsheet software, and
Word Processing software
Other Skills and Abilities:
Ability to read, analyze, and interpret professional journals,
SOPs, technical procedures, or governmental regulations. Ability to
write protocols, reports, business correspondences, and procedure
manuals. All communication must be in English. Ability to
comprehend and apply principles of calculus, modern algebra, and
statistics. Ability to define problems, collect data, establish
facts, and draw valid conclusions from these observations. Computer
Skills: Ability to utilize MS Office, Databases, and preferably PLC
Ladder Logic.
Other Qualifications:
Physical Demands:
While performing the duties of this job, the employee is regularly
required to talk or hear. The employee is frequently required to
sit and use their hands to handle or feel. The employee is
occasionally required to stand, walk, reach with hands and arms;
climb or balance and stoop, kneel, crouch, or crawl. The employee
must regularly lift and /or move up to 10 pounds, frequently lift
and/or move up to 25 pounds and occasionally lift and/or move up to
50 pounds. Specific vision abilities required by this job include
close vision, distance vision, color vision, peripheral vision, and
depth perception.
Work Environment:
While performing the duties of this Job, the employee is
occasionally exposed to moving mechanical parts; high, precarious
places; fumes or airborne particles; toxic or caustic chemicals;
risk of electrical shock; explosives; risk of radiation, and
vibration. The noise level in the work environment is usually
moderate.
All interested applicants must apply online. Curia is an Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against based on disability.
Note
This job description in no way states or implies that these are the
only duties to be performed by the employee(s) incumbent in this
position. Employees will be required to follow any other
job-related instructions and to perform any other job-related
duties requested by any person authorized to give instructions or
assignments. All duties and responsibilities are essential
functions and requirements and are subject to possible modification
to reasonably accommodate individuals with disabilities. To perform
this job successfully, the incumbents will possess the skills,
aptitudes, and abilities to perform each duty proficiently. Some
requirements may exclude individuals who pose a direct threat or
significant risk to the health or safety of themselves or others.
The requirements listed in this document are the minimum levels of
knowledge, skills, or abilities. This document does not create an
employment contract, implied or otherwise, other than an "at-will"
relationship.
Keywords: Curia, New Haven , Senior Principal Validation Engineer - ABQ, Other , Amityville, Connecticut
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