At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours.
Role reports to:
SA Engineering and Reliability Campus Leader
Location:
Europe/Middle East/Africa, South Africa, Gauteng, Johannesburg
Work Location:
Fully Onsite
What you will do
C & Q technician
This position reports into Engineering & Reliability Leader and is based in Cape Town, South Africa.
What we do
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent.
Who we are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here.
Role reports to:
SA Engineering Campus Lead
Location:
Cape Town, South Africa
Travel %: Minimal
Pay:
24
What you will do
What you will do
The Commissiong & Qualification technician is responsible for generating and maintaining the validation plan in line with GMP and successfully carry out on all Facilities, Utilities (HVAC, Water, Compressed Air and other), Equipment, Systems.
Key Responsibilities:
Development of User Requirement Specifications
Development and execution of System Impact Assessments and Component Impact Assessments
Development and execution of Validation Risk Assessments and Design Reviews
Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
Perform Commissioning (includes Factory Acceptance Testing and Site Acceptance Testing) as required and liaise with other departments
Validation of Automated Systems
Perform periodic reviews for Equipment, Facilities, Utilities, Systems
Re-qualification of Equipment, Facilities, Utilities, Systems
Interact with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, contractors and other intended parties
Follow and review site validation/qualification SOP's to ensure they are in line with current compliance requirements from corporate and regulatory authorities
Participate in corporate, regulatory and internal audits
Maintain up to date knowledge of corporate and regulatory standards
Manage and maintain company validation plan and ensure validation/ qualification activities are successfully carried out
Maintain the Validation Master Plan schedule and Validation System
What we are looking for
Required Qualifications
Relevant Degree in Life Science/Chemistry/Math (Not necessarily from Biology/Microbiology) or equivalent
3-5 years' experience of qualification/validation in a Pharmaceutical company
Experience with cGMP, cGEP, cGDP
Strong problem-solving skills and documentation experience preferred
Strong organizational and time management skills.
Qualifications background.
Desired Qualifications
Very strong Quality Analytics knowledge and understanding (ISO / FMEA / HAZOP etc.)
Demonstrated knowledge of working within a quality management system and cGMP and regulations 21 CFR 211, EU Annex 11 and 21 CFR Part 11
Must have knowledge of Deviations, Investigations, Change Control, CAPA and Risk Assessments within the Pharmaceutical Industry quality system
Must have basic Protocol and execution and Report writing skills
Ability to work independently and as part of a team
Proficiency in relevant software and tools
Proficiency in Microsoft Office, including Word, PowerPoint, and Excel.
What's in it for you
Competitive Benefit Package
Learning & Development Opportunities
Kenvuer Impact Networks
This list could vary based on location/region
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
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