Changing lives. Building Careers.
Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
Responsibilities associated with his position are directly associated with the introduction and launching of new products and processes into a manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high-level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment, but also as the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting. This position reports into the Anasco, Puerto Rico office, but may work remotely at times.
Qualified candidates must possess relevant experience in one or more of the following areas of validation:
Packaging Validation
Equipment Qualification
Process Validation
Test Method Validation
Cleaning Validation
Utility / Clean Room Validation
Temperature Mapping Studies
Statistical Sampling
ESSENTIAL DUTIES AND RESPONSIBILITIES
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.
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.
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
Develop statistically based sampling plans for in-process and final test sequencing.
Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments and suggestions associated with validation and engineering documentation.
Protocol, Deviation, and summary report generation and approval.
Change control, non-conformance and CAPA support.
Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
2 to 5 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 and conflict resolution.
Excellent technical writing skills with a thorough understanding of good documentation
practice. Experience using temperature mapping equipment including Kaye Validators and Valprobes.
Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
Ability to travel 10%.
Fluent in both English and Spanish.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, write/type, and move through all locations of a manufacturing facility. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Must be able to independently travel via car or airplane to domestic and international locations as needed.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo