Senior Engineer Lab Support

Location: Devens, MA

• Top Requirements:
  • Experience in the pharmaceutical industry working in a regulated GMP environment
  • Experience with the administration of IT/computer systems
  • Experience with PC build and configuration
  • Experience configuring equipment for GMP manufacturing

Summary:
Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing areas.

Responsibilities:
• Coordinate Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support.
• Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.
• Participates in regulatory audits as Digital Plant secondary representative and assists in generating responses to audit observations.
• Provides IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities.
• Interact with Infinity (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed.
• Interact with ServiceNow to review and approve digital changes.
• Provide quality support of Digital Plant programs and system maintenance activities.
• Responsible for routine completion of quality events, quality actions, risk assessments, and other compliance documentation.
• Ability to support on-call deviations on a rotational basis.
• Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.
• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.
• Duties may include internal compliance or efficiency improvement efforts within department.
• Mentor other IT Digital Plant staff and provide guidance as necessary.

Qualifications:

• BS degree in life sciences, engineering or computer field or equivalent experience.
• Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
• Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications
• Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
• Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
• Demonstrated leadership skills and the ability to negotiate in a complex environment.
• Excellent verbal and written communication skills.
• The ability to plan and lead small and medium size projects and enhancements.
• Self-driven and capable of prioritizing.
• Understanding of network, databases, servers, and PCs.
• Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
• Ability to apply lean and OpEx principles.
• Represent the department before our stakeholders, regulatory agencies, and management