Senior Validation Engineer I - Integra LifeSciences
Mansfield, MA
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
Qualified candidates must possess relevant experience in one or more of the following areas of validation and be considered a Subject Matter Expert in one area:
+ Equipment Qualification
+ Process Validation
+ Test Method Validation
+ Cleaning Validation
+ Statistical Sampling
- Responsibilities associated with this position are directly associated to conducting validations related to new product introduction (NPI), product transfers, and other validation projects.
- Well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint.
- Understand risk-based sampling. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation.
- Be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. An understanding of cGMP environments is required.
- Understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
+ Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
+ Determine scope and path forward for validation requests.
+ Must be able to read and understand engineering P&ID's and turnover documentation.
+ Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
+ Serve as validation representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract validation resources.
+ Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.
+ Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
+ Ensure compliance in area of subject matter expertise across the company.
+ Support and address comments and suggestions associated with validation and engineering documentation.
+ Change control, non-conformance and CAPA support.
+ Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ Bachelor's degree in engineering (Quality, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry) in preferred.
+ 4-7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
+ Demonstrates excellent organizational and communication skills.
+ Results oriented with a strong focus on quality principles.
+ Excellent technical writing skills with an understanding of good documentation practice.
+ Experience conducting validation studies and managing projects independently.
+ Ability to track milestones and manage validation projects.
+ Working knowledge of applicable regulations and their interpretation within industry.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
Qualified candidates must possess relevant experience in one or more of the following areas of validation and be considered a Subject Matter Expert in one area:
+ Equipment Qualification
+ Process Validation
+ Test Method Validation
+ Cleaning Validation
+ Statistical Sampling
- Responsibilities associated with this position are directly associated to conducting validations related to new product introduction (NPI), product transfers, and other validation projects.
- Well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint.
- Understand risk-based sampling. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation.
- Be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. An understanding of cGMP environments is required.
- Understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
+ Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
+ Determine scope and path forward for validation requests.
+ Must be able to read and understand engineering P&ID's and turnover documentation.
+ Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
+ Serve as validation representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract validation resources.
+ Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.
+ Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
+ Ensure compliance in area of subject matter expertise across the company.
+ Support and address comments and suggestions associated with validation and engineering documentation.
+ Change control, non-conformance and CAPA support.
+ Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ Bachelor's degree in engineering (Quality, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry) in preferred.
+ 4-7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
+ Demonstrates excellent organizational and communication skills.
+ Results oriented with a strong focus on quality principles.
+ Excellent technical writing skills with an understanding of good documentation practice.
+ Experience conducting validation studies and managing projects independently.
+ Ability to track milestones and manage validation projects.
+ Working knowledge of applicable regulations and their interpretation within industry.
Source : Integra LifeSciences