IT Applications Administrator and Compliance
Plainsboro, NJ

Job Description

Overview

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions.

At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life.

Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries.

We are seeking an IT Systems Administrator and Compliance within our IT Department located in Plainsboro, NJ.

Responsibilities

Job Summary: This position supports the Laboratory software systems and associated software systems, for the Plainsboro/Cranbury, NJ sites. The position will also be involved with implementing and upgrading of these specific systems.

Essential Job Functions:

* To be responsible for the day to day support of IT infrastructure of regulated systems.
* To be the central point of contact for all regulated system support issues reported to the IT helpdesk.
* Work with the QA and Validation team as required.
* To respond to emergency requests for support in a timely manner and escalate appropriately.
* Under change management processes provides support of preparing, reviewing, approving, and implementing system changes and enhancements.
* Drive necessary improvements in IT infrastructure related to the laboratory system applications to improve the overall efficiency and effectiveness.
* Meet regularly with IT/QA/Validation/end-users to analyze their processes and needs and employ comprehensive knowledge to assist in decision making.
* Interface with sponsor and regulatory audits as directed by IT management
* Responsible for regulated systems user management, security management, backup/restore, and disaster recovery.
* Maintain records and documentation for areas of responsibility as required by SOPs
* Responsible for the technical support during the computerized system issue trouble shooting.
* Participate in the on-call system for IT support, and adhere to flexible working arrangements as necessary.

Qualifications

Job Requirements

Experience / Education:

* BS in computer science, EE, relevant science major.
* Possesses 2-4 years (preferably 3-5 years) experience in a laboratory environment
* Understanding of GLP, and 21 CFR part 11 for validated electronic data systems in a laboratory environment
* Previous experience in Applications and Systems administration in a pharmaceutical lab environment a huge plus.
* Well organized, able to work on multiple projects.
* Demonstrated knowledge of and experience with SDLC/Validation and system life cycle methodology preferred.
* Experience with data analysis.
* Skills and experience working in culturally diverse, multi-disciplined work groups with the ability to manage multiple priorities and be self-directed in a fast paced environment
* Familiar with GLP, FDA, 21 CFR Part 11 is required.
* Solid knowledge with Windows and Windows server technology, and network.

Knowledge / Skills / Abilities

* Well organized, detail oriented, and adaptable to changes
* Effective oral and written communication skills
* Excellent interpersonal skills
* Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint, and other applicable software
* Ability to work under pressure of multiple projects and deadlines
* Ability to effectively prioritize workload and manage changes in direction
* Ability to work in a team environment
* Familiarity with and adherence to regulatory guidelines consistent with XBL requirements

Physical Requirements:

* Must be able to work in an office environment with minimal noise conditions.
* Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals
* Must not have animal allergies to applicable species in this facility
* Must be able to wear appropriate PPE
* Must be able to work in environment with variable noise levels
* Ability to stand /Sit/walk for long periods of time
* Ability to crouch, bend, twist, and reach
* Ability to push/pull 10 lbs routinely/ often / occasionally
* Clarity of Vision
* Ability to identify and distinguish colors
* Must be able to perform activities with repetitive motions
* Ability to climb Ladders / Stairs / Scaffolding
* Ability to work in variable temperatures high to freezing
* Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.