Analytical Validation Engineer - Synectics : Job Details

Description:

• This position is based indoors, and the employee will primarily be working with others, but also independently.
• 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.
• Create Computer System Validation (CSV) Plans, requirement specifications, and test scripts and coordinate associated activities following 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 and Engineering, Validation, Manufacturing, Manufacturing Engineering, Quality Assurance and Quality Control groups.

Qualifications:

• 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.
• Experience and understanding of 21 CFR Part 11, GAMP compliance for computer system (hardware, application software and operating system).
• Frequent repeated motions such as keyboarding is required.
• Validation experience with automation and enterprise systems; the candidate can have system validation knowledge; they will consider candidates with non-pharma experience.

Benefits: Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer.