Overview
On Site
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
CSV
DOCUMENTATION
TECHNICAL WRITER
Job Details
Primary Talent Partners has an open 12 month W2 contract with a large biologics client of ours in the Syracuse, NY area.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
Pay Range: $52.00 to $57.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to)
Job Responsibilities
Responsible for preparing computer system validation documents to comply with local and global regulatory requirements, and internal company standards. Ensure IT personnel complete QMS actions and routine system compliance activities are completed on time within *** Biologics Digital Plant (DP).
- Create Computer System Validation (CSV) Plans, requirement specifications, and test scripts and coordinate associated activities following *** Biologics CSV program.
- Support Automation execution of CSV deliverables such as architecture diagrams, configuration specifications, and executing test scripts.
- Monitor IT Service Management tickets to ensure robust ticket compliance per company standards.
- Independently work with complex issues related to day-to-day activities and escalate issues when necessary.
- Actively participate with others to analyze and address process deficiencies.
- Work collaboratively with others in the Facilities & Engineering, Validation, Manufacturing, Manufacturing Engineering, Quality Assurance, and Quality Control groups.
Qualifications
Specific Knowledge, Skills, Abilities, etc.:
- A bachelor s degree is preferred OR Associate degree with at least 1 to 3 years experience working in the pharmaceutical industry or industry regulated by GMP standards and requirements.
- Proactive, self-starter with good decision-making skills and capable of working alone or in a team environment to develop CSV documentation and to propose mitigations to problems and gaps identified.
- Experience and knowledge in Computer/Software validation (creating validation plans, URS/FRS documents, IQ/OQ/PQ, and validation summary reports).
- Technical writing experience preferred.
- Experience with building automation systems, manufacturing execution systems, or enterprise systems preferred.
- Proficiency in written and verbal communication skills with the ability to effectively collaborate with technical and senior management staff.
- Experience in data governance, data integrity (DI) assessment, audit trail review, security, user access review, trace matrices, etc. is preferred.
- Ability to work effectively under pressure, handle multiple projects, and meet deadlines.
- Ability to develop and apply new and innovative approaches to projects and processes; a working understanding of lean principles and establishment of effective process metrics is preferred.
- Adhere to QA policies and procedures (SOPs), training materials, and tools to ensure DP meets quality standards and regulatory requirements.
Education/Experience/Licenses/Certifications
- Experience and understanding of 21 CFR Part 11, GAMP compliance for computer systems (hardware, application software, and operating system).
- Bachelor of Science in Engineering, Computer Science, or equivalent technical degree or equivalent applicable experience preferred.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at
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