The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Mwx16d6bzmn4dyh1dwd

Validation Engineer for Pharmaceutical Manufacturing

Job Description

VALIDATION ENGINEER FOR PHARMACEUTICAL MANUFACTURING
BRANCHBURG, NJ 
 
Project Description:
Under general supervision, reviews specifications and determines the critical aspects of facilities, utilities, computer systems and manufacturing equipment with regard to product and process quality, writes qualification protocols for operating systems and records related test results; prepares final reports that identify the results of protocol testing and the conditions of release. 
 
  • Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. 
  • Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment. 
  • Assures that protocols are approved through proper channels; writes and revises validation protocols. 
  • Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met. 
  • Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization. 
  • Assures that all test data is gathered and recorded in accordance with cGMP requirements. 
  • Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria. 
  • Writes final reports and assures that they are approved through proper channels. 
  • Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas. 
  • Develops and communicates project timelines and status. 
  • Complies with all GMP and safety requirements, SOP's and Company policies and procedures. 
  • Performs related duties as assigned. 
  • Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors.
  • Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results 
  • Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring. 
 
Required Skills:
  • Bachelor's degree in Engineering or a related field from an accredited college or university and zero (0) to one (1) year of engineering validation experience, preferably in a pharmaceutical environment, or an equivalent combination of training and experience.
  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. 
  • Pharmaceutical principles, practices and applications. 
  • English usage, spelling, grammar and punctuation. 
  • Principles of mathematical and statistical computations. 
  • Personal computer operations and Microsoft applications (Word, Access, and Excel). 
  • Interpreting software and ladder logic diagrams and flowcharts.
  • Interpreting electrical and mechanical blue prints and specifications including HVAC systems and. construction plans.
  • Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
  • Communicating clearly and concisely, both orally and in writing.
  • Establishing and maintaining good relationships with those encountered in the course of work.
 
Physical Requirements and Working Conditions:
  • Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment.
  • Work is performed in a manufacturing environment. 
 
This 6+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com
 
ALPHA'S REQUIREMENT #19-01056
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

#ZR

Job Requirements

 

Job Snapshot

Location US-NJ-Branchburg
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Engineering & Aerospace
Apply

Company Overview

Alpha Consulting

Alpha Consulting Corporation is a privately owned staffing firm in East Brunswick, NJ. Alpha has staffed IT positions for major companies in the pharmaceutical industry since 1994. Alpha's experienced recruiters, account managers, and support staff have a combined 75+ years of placement experience and focus on finding a strong match between assignment and consultant. Alpha offers direct deposit, a comprehensive medical plan, and a 401K plan. We hope to help you find your next opportunity soon! Learn More

Contact Information

US-NJ-Branchburg
Bridget Burns
Snapshot
Alpha Consulting
Company:
US-NJ-Branchburg
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

VALIDATION ENGINEER FOR PHARMACEUTICAL MANUFACTURING
BRANCHBURG, NJ 
 
Project Description:
Under general supervision, reviews specifications and determines the critical aspects of facilities, utilities, computer systems and manufacturing equipment with regard to product and process quality, writes qualification protocols for operating systems and records related test results; prepares final reports that identify the results of protocol testing and the conditions of release. 
 
  • Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. 
  • Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment. 
  • Assures that protocols are approved through proper channels; writes and revises validation protocols. 
  • Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met. 
  • Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization. 
  • Assures that all test data is gathered and recorded in accordance with cGMP requirements. 
  • Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria. 
  • Writes final reports and assures that they are approved through proper channels. 
  • Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas. 
  • Develops and communicates project timelines and status. 
  • Complies with all GMP and safety requirements, SOP's and Company policies and procedures. 
  • Performs related duties as assigned. 
  • Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors.
  • Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results 
  • Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring. 
 
Required Skills:
  • Bachelor's degree in Engineering or a related field from an accredited college or university and zero (0) to one (1) year of engineering validation experience, preferably in a pharmaceutical environment, or an equivalent combination of training and experience.
  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. 
  • Pharmaceutical principles, practices and applications. 
  • English usage, spelling, grammar and punctuation. 
  • Principles of mathematical and statistical computations. 
  • Personal computer operations and Microsoft applications (Word, Access, and Excel). 
  • Interpreting software and ladder logic diagrams and flowcharts.
  • Interpreting electrical and mechanical blue prints and specifications including HVAC systems and. construction plans.
  • Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
  • Communicating clearly and concisely, both orally and in writing.
  • Establishing and maintaining good relationships with those encountered in the course of work.
 
Physical Requirements and Working Conditions:
  • Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment.
  • Work is performed in a manufacturing environment. 
 
This 6+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com
 
ALPHA'S REQUIREMENT #19-01056
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

#ZR

Job Requirements

 
Mwy2xl6gf6wd76vjwfp
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Validation Engineer for Pharmaceutical Manufacturing Apply now