Analytical Validation Engineer Position Available In Onondaga, New York

Analytical Validation Engineer#25-63015
East Syracuse, NY
All On-site Job Description Responsible for preparing computer system validation documents to compliance 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 Lotte Biologics Digital Plant (DP).
Duties/Responsibilities

• Create Computer System Validation (CSV) Plans, requirement specifications, and test scripts and coordinate associated activities following Lotte Biologics CSV program.
• Support Automation execution of CSV deliverables such as architecture diagrams, configuration specifications and executing test scripts.
• Moitor 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. Quals–
  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 of written and verbal communication skills with 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 system (hardware, application software and operating system).
• Bachelor of Science in Engineering, Computer Science, or equivalent technical degree or equivalent applicable experience preferred.

Physical Demands:

This is an office-based position which requires appropriate levels of personal protective equipment (PPE) when field work is required.
Frequent repeated motions such as keyboarding is required. Work Environment
This position is based indoors, and the employee will primarily be working with others, but also independently. This position requires personnel presence, onsite 50-100%. This position is a team and project-based position that may require occasional shift work, weekends, and holidays.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”