Entegee
Summary:
Seeking CSV Engineers to author qualification reports, review validation protocols, and ensure compliance with corporate data integrity for manufacturing equipment in a GMP regulated environment.
Requirements:
Experience working in a GMP regulated environment.
Proven experience authoring IQ/OQ final reports for application upgrade projects.
Proficient in reviewing and authoring validation protocols including IQ, OQ, PQ related to computer systems for manufacturing equipment (e.
g.
, bioreactors, TFFs, tube welders).
Ability to author and review Validation Deliverables:
VMP, System Impact Assessment, Risk Assessment, URS Document, Design Specification Document, Configuration Specification document.
Preferred Skills:
Familiarity with Data Integrity Assessments and application qualification protocols.
Ensuring site systems are compliant with corporate Data Integrity programs.
Capable of independent work on assigned tasks without the need for mentorship.
Strong interpersonal skills for effective communication and collaboration across various levels of the client's organization.
Aptitude for identifying business expansion opportunities and reporting to management.
Responsibilities:
Author Qualification (IQ/OQ) Final Reports for application upgrade projects within specified timelines.
Review validation protocols including IQ, OQ, PQ related to computer systems for a range of manufacturing equipment.
Produce comprehensive Validation Deliverables such as VMPs and Validation Summary Reports.
Maintain compliance with corporate Data Integrity program across site systems.
Pay Details:
$31.
00 to $42.
00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.
In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.
entegee.
com/candidate-privacy-information-statement/The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
About the Company:
EntegeeENTEGEE has over fifty years of experience in providing Fortune 500 and other companies with highly qualified technical personnel.
All our offices combined currently employ over 2500 contract engineering and programming specialists, and maintain an internal staff of over 300 successful recruiting and customer service personnel.
Our reputation for quality personnel and responsiveness has established us as a primary supplier to companies throughout the U.
S.
and abroad.
ENTEGEE has an internal engineering staff that greatly increases our technical knowledge and improves the quality of technical personnel we can supply.
To Read our Candidate Privacy Information Statement, which explains how we will use your information, please visit:
http:
//www.
entegee.
com/candidate-privacy-information-statement/The Company will consider qualified applicants with arrest and conviction records.
Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
1958Website:
http:
//www.
entegee.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
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