Johnson & Johnson Careers
Validation Packaging Manager F/M
Requisition ID: 1805682801W
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
SCOPE OF THE ROLE AND BASIC PURPOSE
In alignment with the Regional Validation Leader, the SME Validation supports the execution of Filling and Packaging Validation across the regional Consumer organization to ensure compliant and efficient performance consistent with established J&J guideline and policies.
For the specific technological area of competence, he/she is the regional subject matter expert for filling and packaging validations. His /Her specific area of responsibilities includes developing, finalizing, and implementing regional validation protocols and reports aligned with global guidelines. He/She will work closely with regional and global team in developing and standardizing validation and qualification policies, procedures.
- Be well-versed in the principles and approaches of filling and packaging validation in the regional Consumer organization.
- Support site team to complete and execute validation protocols and reports in a timely and compliant manner to meet project and business objectives
- Support the development and continuous optimization of Consumer Products Validation program improving approaches to validation execution based on risk management approach.
- Work closely with the Global Technology leaders for Global Technology & Regional Validation organization to define standards, harmonized procedures, and streamlined templates.
- Define and implement process excellence (PE) and cost improvement (CIP) projects.
- 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) in the team; provide validation oversight and guidance regionally/locally with GTO personnel. Responsible for communicating and elevating critical business-related issues, as well as opportunities, to senior management.
- Serve as SME in providing support 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.
- Collaborate 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.
- Leads investigation, root cause analysis, corrective and preventive action plan subsequent to observations made during internal audit, JJRC audit , regulatory team inspection.
- Be informed about consumer complaints trends and manufacturing defects to understand improvement opportunity at design and qualification stage and provides input to respective team.
1. Required Education/Training and/or Experience:
- Bachelor’s degree in physical sciences, Engineering, Packaging or appropriate related equivalent field
- 7-10 years’ experience in related field – packaging, engineering, qualification.
- Validation expertise
- GMP knowledge is required. Cosmetic and Consumer product knowledge is strongly preferred.
- Have experience in performing trials, qualifications, validations in a regulated environment.
- Strong knowledge of principles in validation and current industry approaches.
- Project Management experience strongly preferred.
- Experience in Health Authorities inspection management preferred
2. Required Skills/Abilities:
- Effective team collaboration skills
- Effective written and oral communication skills (English is a requirement).
- Effective in conflict management and influencing skill.
- 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.
- Demonstrated abilities in outside –in approach for process improvement and innovation.
Europe/Middle East/Africa-Greece-Attica-Attica, Europe/Middle East/Africa-Italy-Lazio-Pomezia
Janssen Cilag S.A.S. (7825)