Senior Information Systems Specialist

3 weeks ago

Cranbury, United States Experic Full time $150,000 - $175,000
Job DescriptionJob Description

Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.

Summary/Objective

The Senior Information Systems Specialist will apply their knowledge of operations and production systems to ensure compliant administration of Validated Systems in the Experic manufacturing and research facility. This position will evaluate validated hardware, software and combination systems for risks, remediation actions and improvement to the design and architecture in place. This position will analyze the functionality of current systems and operations processes to generate requirements for the development of new or modified functionality, implementation of fixes or upgrades to new or existing systems and software to ensure that systems function optimally and that all deadlines are met. Additionally, this position will provide training and support for computer hardware and software services to end users.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

  • Evaluation and documentation of the current IT architecture, workflows, and capabilities to identify what will need to be addressed to ensure conformance for cGxPs.
  • Implementation of optimized and new workflows for key systems, including integrations that meet Experic's business and regulatory requirements.
  • Responsible for system installation, configuration, user acceptance testing, tuning, maintenance and audit support of validated systems.
  • Provide oversight of quality and regulatory compliance for future software development to ensure conformance for cGxPs.
  • Evaluate, analyze, and communicate systems requirements on a continuing basis, and maintain systems processes.
  • Ability to operate computer and peripheral equipment and software applications; obtain accurate and complete information from users to identify their needs and problems and develop responses and solutions.
  • Monitor performance, connectivity, users, processes, backups and perform troubleshooting and tuning of systems and infrastructure.
  • Responsible for application related problem-solving and troubleshooting.
  • Create, maintain, and update documentation.
  • Responsible for producing functional requirements from operations use cases and articulating those requirements to system vendors.
  • Assurance of ongoing compliance to information security policy, process, standards, and guidelines as well as associated artifacts from external governing bodies, regulations, and laws, such as GDPR, 21CFR part 11 (E-Signatures), Annex 11, Annex 15, HIPPA.

QUALIFICATIONS: EDUCATION and/or EXPERIENCE

At least five (5) years of information systems experience in a pharmaceutical industry or federally regulated business environment required.

Bachelor's degree in information systems, Computer Science, Engineering, or other related discipline preferred.

Project management experience preferred.


OTHER SKILLS, ABILITIES OR QUALIFICATIONS

  • The ability to build relationships and teams across organizational boundaries by effectively communicating, cooperating, and collaborating with all technology stakeholders.
  • Ability to understand and follow the system design and architecture.
  • Ability to learn and actively seek new skills and knowledge to keep up with the changing technology field.
  • Ability to work independently and prioritize risk.
  • Ability to work efficiently in a fast-paced environment, work under pressure and deadline.
  • Ability to be flexible and adapt to any given situation.
  • Knowledge of systems engineering and systems administration best practices and tools specific to area of support.
  • Skilled at enabling innovation through understanding and communication of IT trends and emerging technologies that can create business value.
  • Excellent customer service and stakeholder relationship management skills including strong business acumen and ability to translate to multiple stakeholder groups.
  • Demonstrated experience working in a cGxP environment.
  • Familiarity with PRIORITY ERP and ACE QMS systems
  • Ability to work with others in a team environment.
  • Ability to work overtime as required.

TRAVEL

  • Domestic travel will be required less than 10% of the time.

EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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