Job description
On-Board Services is hiring an QC Lifecycle Validation Engineer in
Devens, MA!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Overview/Summary:
Qualifications:
Requirements:
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 23-01473
TAG
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
- Job Location:Devens MA
- Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
- Compensation: $62 -64 an hour
- Hybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)
Overview/Summary:
- Act as the project lead for qualification of QC equipment and its associated software
Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), - validation plans, equipment IOQ
- protocols, software test scripts, configuration specifications, risk assessments, qualification summary reports.
- Author/execute computer system validation scripts using an electronic validation database (ALM) or paper based as required.
- Own change controls specific to the qualification of QC instruments and its associated software Update the asset management database to reflect new assets, calibrations, preventative maintenance.
- Author instrument operational SOPs as needed.
- Coordinate/interface/host vendors on site
- Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client)
- Acts as the liaison between Digital Plant (IT) and lab departments
Qualifications:
- Bachelor’s degree in relevant scientific, engineering, or computer-based area with 5 – 7 years’ experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.
- investigations, deviations, electronic validation databases, asset management database
- Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP,
- Incumbents must have demonstrated experience in solving complex technical issues and have the skills andunderstanding to troubleshoot process defects.
- Working knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.
Requirements:
- Must have equipment validation experience
- Must have GMP experience
- Must have Quality Management System (QMS) experience
- Experience in Computer System Validation is a plus.
- Experience in any asset management software is a plus.
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 23-01473
TAG
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