Principal Scientist, CSV Lead (Computer System Validation)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Spring House, Pennsylvania, United States of America

Job Description:
About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Principal Scientist, CSV Lead (Computer System Validation) to be in Spring House, PA.

Purpose:

This position is a computer system validation lead position within the Bioanalytical Discovery and Development Sciences (BDDS). We work with internal bioanalytical groups to ensure the completion of all activities related to computer system validations with focus on data integrity and life cycle management of all computerized systems. The bioanalytical team supports all therapeutic areas within Johnson & Johnson, spanning nonclinical studies to post-market clinical development.

You will be responsible for:

• the proper conduct and documentation of validations for equipment computer systems, spreadsheet validation and change control processes as well as provide guidance on validation strategies.
• overall compliance with regulatory and business requirements such as GLPs and 21 CFR part 11 regulations as well as company procedures.
• good interpersonal skills and attention to detail. Communication with the system administrator, system owner, vendor, IT and lab manager to plan, coordinate, implement and validate new technologies.
• leading the compliance profile of computer systems and e-records in BDDS, computer system inventories and computer system validation process.
• the primary management of leading validation projects, developing strategies, prioritizing resourcing and developing teams. This role will represent BDDS on computer system validation activities and process enhancements.
• participating on internal/external working groups/committees as appropriate.
• supporting management of audit programs for GxP software systems.

Qualifications / Requirements:

Education:

• A minimum of a Bachelors degree is required
• A Masters degree or PhD is preferred

Required:

• A minimum of 8 years relevant professional experience is required
• Strong expertise in areas of GLP/GCP is required including knowledge of CSV and data integrity regulations including but not limited to 21 CFR Part 11
• Excellent communication, social skills, networking skills, a high level of organizational ability, and attention to detail is required
• Strong knowledge and experience of computerized system development life cycle approaches and validations strategies is required
• Ability to work independently to make decision and flexible to adjust to changing priorities is required

Preferred:

• Ability to identify problems and process improvement opportunities and drives resolution is preferred
• Familiarity with bioanalytical work and workflows, instrument software, and computer systems validation in the bioanalytical space is preferred
• People management experience is preferred

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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