Validation Process Engineer, OTC and Cosmetics

Job description

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Validation Process Engineer, OTC and Cosmetics. This position is located in Lititz, PA.

Johnson & Johnson Family of Companies touches more than a billion people's lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Position Summary

In alignment with the Regional Validation Leader the Validation Process Engineer, OTC and Cosmetics, will serve as Subject Matter Expert (SME) to support and manage execution of Process, Cleaning and Packaging Validations for JJFCC Cosmetic and OTC products across the regional Consumer organization, ensuring compliance and efficient performance consistent with established J&J guideline and policies.

As Subject Matter Expert (SME) for Process and Cleaning Validations related to Cosmetic and OTC products, he/she is responsible for influencing and supporting validation policies, procedures, and programs, while ensuring effective development and execution of regional validation protocols and reports, Risk and Impact assessment as well as Validation strategy, according to specific regulatory, company and business case requirements.

Key Responsibilities:
· Be well-versed in the principles and approaches of process validation in the regional Consumer organization
· Complete and execute validation protocols and reports, Risk and Impact assessment as well as Validation strategy, in a timely and compliant manner to meet project and business objectives
· Support the development and continuous optimization of JJFCC Consumer Products Validation program, improving approaches to validation execution based upon risk management approach.
· Collaborate with the Global Technology leader for Cosmetics and OTC2 to define standards, harmonized procedures, and streamlined templates.
· Support the development and continuous optimization of JJFCC Consumer Products Validations program, improving compliance and efficiency of validation execution based on a risk management approach.
· Deploy the globally defined standards within the region, aligning with the Global Technology leaders.
· Serve as the regional validation Subject Matter Expert and Point Of Contact (SME-POC) on the team and provide validation oversight and guidance. Responsible for communicating and elevating critical business-related issues, as well as opportunities, to senior management.
· Serve as SME during J&J and Health Authorities inspections/audits.
· Coordinate with all sites in the region to collect performance measures and to release functional report as per plan
· Participate in establishing key performance metrics to evaluate validation efficiency.
· Establish and ensures the rigor of testing during all qualification/validation activities to be consistent with International and local applicable Authorities as well as Company requirements.
· Perform work in compliance with GMP and compliance standards for activities where applicable.
· Contribute to the achievement of company and departmental objectives, while respecting corporate procedures governing the employment relationship and policies for ethical conduct.
· Contribute to the improvement of the quality of the work environment by promoting and encouraging actions consistent with the Corporate Credo.
· Cooperate actively with production Make departments, R&D, SMP, Engineering, GP, QA and QC planning to ensure completion of validation activities in the required mode and time.
· Support investigation of validation problems and in cooperation with the Quality organization in wider investigations
· Carry out work while respecting the procedures and safety rules for him/herself and for the organization.
· Report to the Global Technology leader any situation that could endanger the health and safety of workers and/or the environment.
· Contribute to the containment of departmental costs, while contributing to the improvement and optimization of business processes.
· Define and implement process excellence (PE) and cost improvement (CIP) projects .

Desired profile

Qualifications :

Qualifications
Required:
·  A minimum of a Bachelor degree in Physical Sciences, Engineering, or appropriate related equivalent field and a minimum of six (6) years of related experience is required.
·  GMP knowledge is required.
·  A minimum of one (1) year of experience performing process, cleaning, or other validation in a regulated environment is required.
·  Strong knowledge of principles in validation and current industry approaches are required.
·  Effective team collaboration skills
·  Effective written and oral communication skills (English is a requirement)
·  Experience with technical writing
·  Experience with statistics and statistical analyses
·  Experience with new product development processes and terminology
·  Experience with lifecycle management and product/process changes
·  This position is located in Lititz, PA and may require up to 15% travel both domestically and internationally.

Preferred:
·  Cosmetic and OTC product knowledge is strongly preferred.
·  A minimum of one (1) year of Project Management experience is preferred
·  Experience in Health Authorities inspection management, FDA, ISO preferred
·  Experience working in a regulated industry, FDA, ISO is preferred.
·  Certification in Six Sigma, Statistical Engineering, Lean Six Sigma is preferred.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.