Validation Specialist (24 month), Johnson & Johnson Inc., Guelph, ON-0355140717
Description
Johnson & Johnson Inc. is a member of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. In Canada, Johnson & Johnson Inc. markets innovative consumer products focusing on skin and hair care, baby care, wound care, oral health and women's health as well as a broad range of well-known and trusted over-the-counter products through our McNeil Consumer Healthcare division.
At Johnson & Johnson Inc. our purpose is to "Bring Science to the Art of Healthy Living" by providing Canadians with some of the most world's most widely used and trusted brands including; JOHNSON'S ® Baby, NEUTROGENA®, AVEENO® LISTERINE®, BAND-AID® Brand Adhesive Bandages, TYLENOL®, REACTINE® , BENYLIN® , NICORETTE®, NICODERM® and many more. Based in Markham, Ontario, Johnson & Johnson Inc. employs approximately 400 people and is supported by a manufacturing and R&D facility located in Guelph, Ontario.
The Validation Specialist (24 month) is responsible for maintaining compliance-based systems used in the manufacturing and packaging of products at the McNeil Consumer Healthcare Guelph Campus. The Validation Specialist will ensure that documented evidence exists to provide a high degree of assurance that processes, equipment, computer systems and methods are consistently reproducible and meet the required specifications, comply with Johnson & Johnson and McNeil policies and quality standards, health, safety and environmental regulations, and regulatory requirements (Health Canada and the United States FDA).
MAJOR RESPONSIBILITIES
Review, revise and approve validation documents (i.e. assessments, protocols, reports etc.) to ensure that they are in compliance with relevant Standard Operation Procedures (SOP’s), government regulations and company policies. Validation types may include but are not limited to packaging validation, cleaning validation, process validation, analytical and microbial method validation, equipment qualification and computerized system validation.
Preparation and maintenance of validation policy documents, validation specifications and validation SOP’s to ensure compliance with regulatory governing bodies (Health Canada and the United States FDA), company requirements (McNeil Consumer Healthcare Guelph Campus and Johnson & Johnson Group of Consumer Companies Canada), quality standards and industry trends.
Provide consultation to business partners with interpretation of approved SOPs and policies, in order to support process changes, new equipment or system introductions, technical transfers and product launches.
Evaluate the impact of modifications to processes, methods, equipment or systems to determine the extent of validation required.
Prepare validation assessment reports in support of the site Annual Product Quality Review process.
Ensure all delegated change control tasks are completed in a timely manner.
Maintain all validation documents in a controlled state; hardcopies properly filed in the documentation room and electronic copies saved in the applicable secure file location, duly administered through the document-tracking databases and scanned folders
Qualifications
EDUCATION AND EXPERIENCE
Minimum of a degree or diploma in Science/Engineering or a related discipline or equivalent experience within the chemical/ pharmaceutical industry
Minimum of 3 years experience in the pharmaceutical industry within Quality Assurance, Pharmaceutical Research & Development, or Plant Operations
Knowledge of GMP regulations required.
Knowledge of Process Excellence an asset
COMPETENCIES
Integrity and Credo based actions
Big picture orientation
Strategic thinking
Organization and talent development
Intellectual curiosity
Sense of urgency
Prudent risk taking
Collaboration and teaming
Self awareness and adaptability
Results and performance driven
Strong computer skills specifically in Microsoft Word, PowerPoint, Excel and Adobe Acrobat are required.
Strong technical writing, verbal communication, interpersonal, and problem solving skills is required.
Other key skills include attention to detail, being able to work effectively within a team and as an individual, and able to effectively prioritize tasks.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Guelph
Organization: Johnson & Johnson Inc. (7695)
Job Function: Validation
Description
Johnson & Johnson Inc. is a member of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. In Canada, Johnson & Johnson Inc. markets innovative consumer products focusing on skin and hair care, baby care, wound care, oral health and women's health as well as a broad range of well-known and trusted over-the-counter products through our McNeil Consumer Healthcare division.
At Johnson & Johnson Inc. our purpose is to "Bring Science to the Art of Healthy Living" by providing Canadians with some of the most world's most widely used and trusted brands including; JOHNSON'S ® Baby, NEUTROGENA®, AVEENO® LISTERINE®, BAND-AID® Brand Adhesive Bandages, TYLENOL®, REACTINE® , BENYLIN® , NICORETTE®, NICODERM® and many more. Based in Markham, Ontario, Johnson & Johnson Inc. employs approximately 400 people and is supported by a manufacturing and R&D facility located in Guelph, Ontario.
The Validation Specialist (24 month) is responsible for maintaining compliance-based systems used in the manufacturing and packaging of products at the McNeil Consumer Healthcare Guelph Campus. The Validation Specialist will ensure that documented evidence exists to provide a high degree of assurance that processes, equipment, computer systems and methods are consistently reproducible and meet the required specifications, comply with Johnson & Johnson and McNeil policies and quality standards, health, safety and environmental regulations, and regulatory requirements (Health Canada and the United States FDA).
MAJOR RESPONSIBILITIES
Review, revise and approve validation documents (i.e. assessments, protocols, reports etc.) to ensure that they are in compliance with relevant Standard Operation Procedures (SOP’s), government regulations and company policies. Validation types may include but are not limited to packaging validation, cleaning validation, process validation, analytical and microbial method validation, equipment qualification and computerized system validation.
Preparation and maintenance of validation policy documents, validation specifications and validation SOP’s to ensure compliance with regulatory governing bodies (Health Canada and the United States FDA), company requirements (McNeil Consumer Healthcare Guelph Campus and Johnson & Johnson Group of Consumer Companies Canada), quality standards and industry trends.
Provide consultation to business partners with interpretation of approved SOPs and policies, in order to support process changes, new equipment or system introductions, technical transfers and product launches.
Evaluate the impact of modifications to processes, methods, equipment or systems to determine the extent of validation required.
Prepare validation assessment reports in support of the site Annual Product Quality Review process.
Ensure all delegated change control tasks are completed in a timely manner.
Maintain all validation documents in a controlled state; hardcopies properly filed in the documentation room and electronic copies saved in the applicable secure file location, duly administered through the document-tracking databases and scanned folders
Qualifications
EDUCATION AND EXPERIENCE
Minimum of a degree or diploma in Science/Engineering or a related discipline or equivalent experience within the chemical/ pharmaceutical industry
Minimum of 3 years experience in the pharmaceutical industry within Quality Assurance, Pharmaceutical Research & Development, or Plant Operations
Knowledge of GMP regulations required.
Knowledge of Process Excellence an asset
COMPETENCIES
Integrity and Credo based actions
Big picture orientation
Strategic thinking
Organization and talent development
Intellectual curiosity
Sense of urgency
Prudent risk taking
Collaboration and teaming
Self awareness and adaptability
Results and performance driven
Strong computer skills specifically in Microsoft Word, PowerPoint, Excel and Adobe Acrobat are required.
Strong technical writing, verbal communication, interpersonal, and problem solving skills is required.
Other key skills include attention to detail, being able to work effectively within a team and as an individual, and able to effectively prioritize tasks.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Guelph
Organization: Johnson & Johnson Inc. (7695)
Job Function: Validation