Highlights
Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.
Numbers & Facts
| Location | Portsmouth, NH |
| Industry | Computer/IT Services |
| Salary | $45–$55 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.
Job Title: Senior Computer Systems Validation Specialist
Location: Portsmouth, NH 03801
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 1st Shift
Please Note: Applicants must be currently authorized to work full-time in the United States for any employer. This role does not offer visa sponsorship, now or in the future, and only W2 candidates will be considered for this position.
Summary
The Senior Computer Systems Validation Specialist / CSV Specialist Level 3 helps lead team members in assessing new and changing computerized systems to ensure compliance with company policies, procedures, and industry guidance. The role is responsible for risk assessing systems, reviewing change requests and test scripts, drafting protocols, initiating and reviewing GMP documentation revisions, and providing guidance to junior team members. The specialist also serves as the QA CSV representative for both small and large-scale projects.
Responsibilities
- Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs.
- Execute all responsibilities as CSV Project Lead for simple projects.
- Oversee and perform all CSV qualification activities for DeltaV and Syncade systems.
- Perform validation maintenance of computerized systems.
- Review and revise CSV SOPs.
- Review engineering documents, including P&IDs, SOPs, Specifications, and Submittals.
- Assist with audits and inspections.
- Perform other duties as assigned.
- Adhere to cGMP requirements during the manufacture of drug products.
- Notify responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects, and related actions.
- Follow job safety procedures and attend required health and safety training.
- Proactively promote workplace safety and promptly report actual and potential accidents and injuries.
- Comply with company and site safety policies.
Required Skills
- Bachelor's Degree in Computer Science, Software Engineering, or a related field.
- Experience in validating - DeltaV and Syncade + Spreadsheets and Sharepoint is required
- Experience with 21 CFR Part 11 and ISPE GAMP guidelines related to Computer Systems Validation (CSV).
- Experience with QMS processes, including Change Control, Deviations, and CAPAs.
- Experience performing CSV qualification activities for DeltaV and Syncade systems.
- Experience with validation maintenance of computerized systems.
- Ability to review and revise CSV SOPs.
- Experience reviewing engineering documents such as P&IDs, SOPs, Specifications, and Submittals.
- Strong written and oral communication skills.
- Strong organizational and time management skills.
TekWissen Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Similar Jobs
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