-
Qualification Engineer
1 week ago
Tris Pharma Monmouth Junction, United States· Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have ...
-
Qualification Engineer
5 days ago
Tris Pharma Monmouth Junction, United States Full timeTris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have ma ...
-
Qualification Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Philadelphia, United StatesResponsibilities: · Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and all other regulatory requ ...
-
Qualification Engineer, Infrastructure
3 weeks ago
IT Solutions LLC Philadelphia, United StatesTitle: Qualification Engineer, Infrastructure · Duration: Long Term rolling contract · Location: On site preferred in Philadelphia, PA - East Coast required · Specific Job Responsibilities · Responsible for performing validation of computer systems, process automation, equipm ...
-
Qualification Engineer
3 weeks ago
Katalyst HealthCares & Life Sciences Cheltenham, United StatesResponsibilities: Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory require ...
-
SilverTech Chalfont, United StatesThe DB InfraGO AG is responsible for the railway infrastructure as a subsidiary of Deutsche Bahn, with over employees managing a network of approximately kilometers. This puts us at the forefront of European railway infrastructure operators for passenger and freight transport. As ...
-
Development Engineer: Product Development
2 weeks ago
Aurora Technologies Yardville, United StatesJOB ID:2276 · Your Tasks · Development of process steps to improve the functional flatness of wafer chucks · Investigation, further development and innovative use of technologies, e.g. polishing, lapping and grinding processes on ceramics to achieve highly flat surfaces · Analysi ...
-
Senior Molding Engineer
3 weeks ago
Integer Holdings Corporation Trenton, United States Full timeJob Description · SummaryDesigns, details, and implements molding process and equipment solutions which improve safety, quality, delivery and cost for new and existing molding production lines. Utilizes molding and plastics knowledge and expertise to develop molds, tooling, fixt ...
-
Project Engineer
1 week ago
Petroplan Trenton, United StatesThe Project Engineer - Mechanical shall be responsible for the direct oversight of the execution of process engineering and design by the Client's engineering subcontractor. The Project Engineer - Mechanical primarily applies principles, knowledge, and practices of process engine ...
-
Project Engineer
1 week ago
Petroplan Trenton, United StatesPOSITION SUMMARY: · Project Engineer - Electrical shall be responsible for the direct oversight of the execution of the electrical engineering and design by The Client's engineering subcontractor. · The Project Engineer - Electrical primarily applies principles, knowledge, and ...
-
Supply Change Control Engineer
13 hours ago
NavitsPartners Trenton, United StatesPosition: Supply Change Control Engineer · Location: West Point, PA · Duration: 12 months · Job Description: · Individuals will be responsible for the execution of Vendor Change notifications. · They will be responsible for providing and occasionally leading technical support to ...
-
Engineering Manager
1 day ago
GAI Consultants Trenton, United States Full timeGAI Consultants Inc. is seeking a Civil Engineering Manager in our Power Business Unit's Civil and Environmental Business Sector. GAI is an established and growing multi-discipline engineering firm with a growing presence in the Mid-Atlantic. GAI's Power Business Unit focuses on ...
-
Engineering Manager
1 week ago
Generac Trenton, United StatesAt Generac, we don't simply wait for opportunities to come to us. Our teams consistently seek out new and innovative advances in our industry, driving our great success and company growth. We are a leader in the power generation industry that is successfully breaking ground in th ...
-
DoD Skillbridge Training Program, Mechanic
2 weeks ago
Summit Materials Trenton, United States· MECHANIC (Department of Defense Skillbridge Training Program) · Denison, Ponder and Trenton, Texas · Ready for a fast-paced job where you can provide the literal groundwork that connects communities together? Join Summit Materials – a construction materials company leading t ...
-
Certified Chrysler/Stellantis Level 3 Technician
3 weeks ago
Feldman Chrysler Dodge Jeep Ram Woodhaven Trenton, United StatesUp to $15,000 SIGN ON BONUS · Stelantis Level 3 Technician · Feldman CDJR of Woodhaven · At Feldman Automotive & Mark Wahlberg Automotive, we are looking for talented, dedicated individuals with drive. Our rapid growth and fast-paced environment make this an exciting workplace ...
-
Real Property Specialist
3 days ago
Johnson, Mirmiran, and Thompson Inc. Trenton, United StatesJohnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined engineering, architecture, information technology, and related services to public agencies and private clients throughou ...
-
Electrical Project Manager
1 week ago
Actalent Trenton, United States Contract to RegularJOB DESCRIPTION My client is a growing commercial electrical contractor that has dominated the New Jersey market for over 30+ years. They actively compete on a variety of projects scaling from $1 million to over $40 million They pride themselves on longevity and culture with mos ...
-
Chief Product Officer
4 weeks ago
Honeywell Trenton, United StatesJoin the industry leader to design the next generation of breakthroughs · The Chief Product Officer, Connected Life Sciences (CLS) is responsible for the overall strategic vision, conceptualization, investment analysis, value proposition, design, build, deploy, and operational pe ...
-
Principal Automation
1 week ago
Integer Holdings Corporation Trenton, United States Full timeBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers' ...
-
IEW Construction Group, Inc. Trenton, United StatesJob description · IEW Construction Group is a Heavy Civil construction Company seeking a qualified Superintendent to join our dynamic team. IEW is committed to delivering high-quality projects, with a strong reputation for excellence. IEW has built its successful reputation on it ...
Qualification Engineer - Trenton, United States - Tris Pharma
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S.with a focus on development and commercialization of innovative medicines that address unmet patient needs.
We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation.
But of equal importance to each member of the team is how we interact with one another on a daily basis.
We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Our Facilities & Engineering Department located in Monmouth Junction, NJ has an immediate need for an experienced Qualification Engineer.Summary
The Qualification Engineer supports and assists the Facilities & Engineering department with writing and execution of various qualification protocols for production and critical utilities equipment to meet production requirements including deadlines and compliance in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements.
Primary duties/responsibilities
Responsible for Qualification Engineering activities, including writing protocols and reports complying with cGMPs, SOPs and FDA requirements
Responsible for supporting and assisting Engineering qualification function by providing documented evidence all company equipment is qualified and remains in a state of control to deliver processes and products complying to all regulatory and business specifications
Provides Engineering support and collaborates cross functionally with Operations, Packaging and Manufacturing departments on appropriate qualification, programming and troubleshooting issues
Responsible for design, writing and executing qualification protocols, tests and reports including, but not limited to: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for production equipment based on user, quality, technical and functional requirements
Responsible for organizing and maintaining the Engineering File Library.
Creates and revises SOPs, as needed
Maintains Laboratory, Manufacturing and Packaging equipment validation schedules, testing and developmental roll-outs
Prepares appropriate Change Controls and performs associated tasks in an accurate, timely, effective and compliant manner
Requirements
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Bachelors degree in Engineering and minimum 3 years Qualification, Validation and/or related experience in the pharmaceutical or biotechnology industry
Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
Hands on experience working with qualification protocols (i.e., IQ, OQ, PQ)
Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
Proficiency with Microsoft Office, including ProjectExcellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Fluent in English (verbal and written)
Physical requirements
Manufacturing based position
Ability to use Personal Protective Equipment (PPE)
#J-18808-Ljbffr