Senior Engineer – Lab Support

Orion Innovation•Devens, MA

13d

About The Position

Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education. 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.

Requirements

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.

Nice To Haves

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.

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.
Represent the department before our stakeholders, regulatory agencies, and management