Systems Engineer, Operational Technology
Durham, NC 
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Posted 22 days ago
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Systems Engineer in Raleigh, North Carolina. This hybrid onsite and remote role will provide technical support for various manufacturing applications such as Werum/Koerber PAS-X, Blue Mountain RAM, TraceLink, Dell Boomi, and Optel Vision Systems in a regulated, validated environment. Apply now to talk to one of our recruiters to learn more about this progressive career opportunity.

RESPONSIBILITIES
  • Participate in project initiatives for new and existing systems (enhancements or upgrades to existing systems, install new software applications, document user requirements, perform development/configuration of software, execute system and validation testing, create/revise SOP's, and conduct training)
  • Collaborate with software vendors and other UT departments
  • Provide break/fix and administrative maintenance support for designated systems
  • Troubleshoot application errors, database errors, user login issues, and perform routine tasks
  • Contribute to internal team initiatives and process improvement efforts
  • Ensure the continuous, uninterrupted availability/functionality of computer systems and coordinate appropriate resources to respond to outages and emergencies

EXPERIENCE
  • Minimum of 3 years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on Quality and Manufacturing System administration, development, and support required
  • Demonstrated experience with Level 1 or 2 application support
  • Experience working in a computer system support environment utilizing a ticket management system to track and manage support requests
  • Experience in executing projects, system life-cycle process, gathering/documenting requirements, executing protocols, and understanding of methodology for execution
  • Ability to collaborate, communicate, and prioritize workload
  • Manufacturing System Application support experience with Werum/Koerber PAS-X Electronic Batch Record, Blue Mountain RAM, Tracelink Serialization Management System, Optel Vision Systems, and/or ERP systems
  • Demonstrated experience in full project lifecycle software application installations
  • Computer hardware/software validation and change control experience
  • Experience collaborating with tools such as Microsoft Teams, Sharepoint, and Smartsheets
  • Knowledge of MS SQL Server and Windows Server
  • System Integration experience using a Platform As A Service such as Dell Boomi preferred
  • Computer system programming and software development experience preferred
  • Proficient in SQL or Oracle Database Administration

EDUCATION
  • Minimum of Bachelor's Degree in Information Technology, Engineering, or an applicable scientific and/or engineering discipline required
  • Certified Project Management Professional (PMP)-PMI preferred

To be a best-fit your strengths must include:

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent and Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3+ years
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