Sr. Systems Engineer, Compliance Systems

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Yoh - A Day & Zimmerman Company
Engineer, Systems, Quality, Management, Content Management, ERP, SAP, Validation, System, API, FDA
Full Time
Travel not required

Job Description

This is a full time, direct hire opportunity in Norwood Facility, MA

Client is is a Cambridge, Massachusetts-based biotechnology company that is focused on drug discovery and drug development based on messenger RNA

The Sr. Engineer, Compliance Systems will support the delivery of software solutions and administration of Compliance Systems - Quality Management Systems, Document Content Management, Legal Contract Management. The role will be accountable for project delivery, key technical activities such as configuration/customization of system, and compliance and operational support.

Here's What You'll Do:
  • Define functional solutions, determine and perform configuration / programs and develop data strategy
  • Partner with compliance functional management to understand business plan and priorities to help shape the digital strategy
  • Lead technical projects focusing on expanding capabilities of the Compliance systems
  • Performs evaluation and prioritization of system enhancements and capabilities to ensure efficient usage and maintenance
  • Evaluates functional configuration issues and provides advanced support on issue resolution
  • Provide administrator support to operate systems including role management, access management and data management
  • Provide technical design insight within the applications, maintain and improve data model and integrations between compliance systems other systems including ERP, LIMS, LMS and MES
  • Participates in validation activities related to implementation and on-going support
  • Generates standard and custom reports based on business and compliance needs
  • Supports /performs system risk assessments and testing quarterly or yearly to support vendor software releases and patches
  • Supports planned and unplanned inspections/audits

Here's What You'll Bring to the Table:
  • Bachelor's degree in science, technology or another relevant academic discipline
  • 6-8 years of experience implementing and maintaining technology to support compliance processes in a regulated biotech or Pharma company
  • Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions
  • Quality orientated with strong attention toward detail
  • Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously in a fast-paced environment
  • Understanding of industry technology trends in quality management, document management and learning management.
  • Experience with SAP, Veeva Vaults (eTMF, Quality (Docs and eQMS) and Submissions), SAP SuccessFactors Learning Management, Please Review, Validation Management System (Kneat), Agiloft Contract Management or similar technologies
  • Expertise with computer systems validation practices (GAMP).
  • API, data report development and systems integration
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer system validation and data integrity
  • Technical writing skills required

Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

#diceSP


Company Information

Are you a .NET mastermind, world class DBA, Java guru or SAP pro? Perfect, because Yoh wants to match your career aspirations with the job demands of today.
Dice Id : 10107614
Position Id : 290893
Originally Posted : 3 months ago

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