- Asset/system decommissioning and documentation lifecycle closeout.
- Asset Decommissioning
- Mechanical Equipment
- System
- Equipment Decommissioning
- CSV Retirement.
- Perform activities related with Validations according to project assignment, customers' needs and requirements and in compliance with cGMP's and Safety procedures
- Investigate client's customer complaints, issues, applicable reports indicating possible cause, and recommend solutions.
- Write/revise/execute Commissioning/Qualification/Validation documents, as applicable, following established standards and templates, including:
- Commissioning Forms
- C/Q/V Protocols and Summary Reports
- Standard Operating Procedures
- Impact/Risk Assessments
- Specifications (URS/FRS/DS)
- Electronic Records/ Electronic Signature (ERES)
- Data Integrity
- Coordinate execution activities as required by commissioning, qualification, validation protocols.
- Provide support to the vendor's installation and commissioning, qualification, validation activities.
- Exhibit a customer-oriented behavior, by clearly understanding customers' needs and expectations, and anticipating possible barriers or obstacles that may impact the project(s) adversely and communicating these on a timely manner.
- Provide support in projects related to process optimization, trouble-shooting, new products and validation of facilities, utilities, and equipment qualification, therefore, responsible for the quality of the product provided to client customers.
- Provide documentation free of errors, controlled and well-organized. (Right the first time)
- Design backup, restoration, archive, and disaster recovery strategy procedures for computer failures.
- Manage technical issues/problems appropriately and efficiently.
- Promote excellent relationship with MENTOR clients, encouraging an open dialog and trustful communication between both parties demonstrating a professional conduct always and proudly represent MENTOR at all levels and places.
- Other responsibilities as assigned by supervisor/management, and/or client.
- Complies with MENTOR's administrative requirements timely and consistently in areas such as: weekly reports, updating of CV's, yearly updates of medical/training records, attendance to work, etc.
- Bachelor's in Engineering, Pharmacy or Science related fields, as a minimum.
- Formal education and training on Equipment/System validation concepts and life cycle.
- Hands-on experience in the development and/or review of decommissioning life cycle documentation and reports.
- Hands-on experience in CQV protocols execution. Tested skills developing Technical Reports.
- Minimum five (5) to eight (8) years of working experience in a pharmaceutical production environment.
- Good interpersonal skills with an assertive and pro-active approach towards work.
- Excellent communication skills (English and Spanish).
- While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus. He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells.
-
Validation Specialist
1 week ago
Mentor Technical Group Cambridge, United StatesMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, ...
-
Takeda Pharmaceutical Cambridge, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I su ...
-
Specialist II, QA Validation
2 weeks ago
ElevateBio Watertown, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Validation Specialist
4 days ago
Premier Life Sciences LLC Canton, United StatesRole: Validation Engineer - CSV/Computer System Validation · Location: Canton, MA - 100% Onsite · Rate: $50-$55/hr on W2 ( No Benefits - No C2C - Negotiable based on experience) · Our client is seeking an experienced Computer Software Validation Contractor with a minimum of 5 yea ...
-
System Validation Specialist
1 week ago
Rees Scientific Corporati Boston, United States**Department: Service** · **Reports To: Regional Service Manager** · **Payroll Type: Salary** · **FLSA Status: Non-Exempt** · **Job Summary**: · As a System Validation Specialist, you have hands on experience with installing, troubleshooting, repairing, calibrating, and inspectin ...
-
Payment Validation Specialist
2 weeks ago
Element Care Lynn, United StatesThe Payment Validation Analyst evaluates claim issues due to billing errors, coding edits, rejections, denials, and payment variances. This position is responsible for updating payment system with rate changes and performing data validation. · ESSENTIAL RESPONSIBILITIES: · Updat ...
-
Specialist II, QA Validation
1 week ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Specialist, Validation Engineer
1 week ago
Bristol Myers Squibb Devens, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Specialist, Cell Therapy Engineering and Validation
19 hours ago
Takeda Cambridge, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Specialist, Validation Engineer
3 weeks ago
Bristol-Myers Squibb Devens, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Validation Specialist III
1 week ago
PSG Global Solutions Bridgewater, United StatesWe're looking for a · Validation Specialist III , working in · Pharmaceuticals · and · Medical Products · industry in · 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States . · Responsibilities: · Monitor commercial business activities. · Validation, analysis ...
-
Validation Specialist II
1 week ago
Azzur Group Devens, United States· About Azzur Cleanrooms on DemandTM · As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azz ...
-
Specialist, Validation Engineer
2 days ago
Bristol-Myers Squibb Devens, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a productio ...
-
Cleaning Validation Specialist
1 week ago
Katalyst Healthcares and Life Sciences Hopedale, United StatesResponsibilities: List primary duties and responsibilities for this position in order of importance and time spent. Include supervisory responsibilities. Focus on responsibilities rather than projects. Avoid being vague or listing many minor duties. · Demonstrate a solid unders ...
-
Specialist, Validation Engineer
8 hours ago
LHC New Devens, United StatesSummary · We are hiring for a Physical Therapy Assistant. · At Three Rivers Home Health, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the ...
-
Specialist Ii, QA Validation
2 weeks ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Specialist, Validation Engineer
3 weeks ago
Bristol-Myers Squibb Ayer, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Validation Specialist III
3 weeks ago
PSG Global Solutions Careers Bridgewater, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Validation Specialist III, working in Pharmaceuticals and Medical Products industry in 55 Corporate Drive, Bridgewater, New Jersey, 08 ...
-
FusionWorks Watertown, United StatesNetwork Administrator (m/f/d) · Full-time, permanent · Cologne · Your responsibilities: · - Administration and maintenance of network components in schools and business clients · - Support of service providers in the installation of network components · - Analysis, diagnosis, an ...
-
25/hour On-Site Attendants
1 week ago
Fooda Cambridge, United States ContractedYou've come to the right place · Fooda is looking for people to help take care of clients and receive incoming bulk orders for lunch. · Must be available Monday to Friday, 10:30am to 1:30pm. · Fooda is looking for a reliable Delivery On-Site Attendant who is concerned with cus ...
Validation Specialist - Cambridge, United States - Mentor Technical Group
Description
Job Description
Job DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Essential Functions:
Responsibilities:
Qualifications Requirements/Knowledge/Education/Skills:
Physical Requirements and Working Environment:
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Powered by JazzHR
wRV8F98MrF