- Responsible for assigned aspects of Technical Services activities while complying with cGMPs, SOPs and FDA requirements
- Responsible for executing TS, Cleaning Validation and Process Validation testing and studies for existing products modified processes; Compiles accompanying study test data to assist and support Scientists in determining processes have met approved and expected validation criteria
- Compiles Critical Quality Attributes (CQA) data on commercial batches for Annual Product Review (APR) and for continues process verification activities and reports; Performs verifications of complied data and other document verification activities, as needed
- Reviews cGMP documents for updates required for Change Control document addendums
- Collaborates with, and assists, Equipment Qualification Engineers on required equipment qualification activities, as needed
- Generates placebo batch records and performs Performance Qualifications (PQ) studies for Equipment Qualifications
- Performs and assists with other Validation tasks and activities as instructed by TS Engineers and/or management
- Adheres to all plant safety policies and procedures
- Exposure to Technical Service /Product Development, Formulation, Process Validation and/or Cleaning Validation through pharmaceutical or biotechnology industry experience
REQUIRED - Understanding and/or exposure in the operation of manufacturing equipment within production of solid and/or liquid oral dosage forms (i.e., tablet press, granulator, fluid bed processor etc.)
REQUIRED - Current working knowledge of cGMPs in the pharmaceutical industry
REQUIRED
This is a 1st shift position but requires flexibility to work periodically on 2nd or 3rd shift for short periods based on validation project needs-
Service Engineer
Found in: Lensa US 4 C2 - 20 hours ago
Bowman Williams Cranbury, United StatesLocation : Cranbury, NJ / · Salary : $70,000 - $80,000 · We are seeking a Service Engineer – MSP with an IT Services background. This company is seeking a tenacious and honest MSP Field Service Engineer that will handle escalated support, project-based work, an onsite consultati ...
-
Remote Pharmacy Technician
Found in: SonicJobs Direct Apply US - 4 hours ago
Actalent Plainsboro, United States Full timeDescription: · •Reviews pertinent information with patients and answers questions · •Handles inbound calls from patients to review documentation and details · •Making outbound calls to providers, patients, and clinics to gather missing information for pharmacists · Additional S ...
-
Quality Assurance Specialist
Found in: SonicJobs Direct Apply US - 4 hours ago
Actalent Plainsboro, United States Full timeActalent is hiring a Compliance Specialist for one of NJ's largest fragrance & flavors companies · Description: · Must be able to write and complete both deviations and investigations · Must be comfortable with working with investigators on completing deviations and investigation ...
-
Quality Assurance Specialist
Found in: SonicJobs Direct Apply US - 4 hours ago
Actalent Plainsboro, United States Full timeActalent is hiring a Compliance Specialist for one of NJ's largest fragrance companies · Description: · Must be able to write and complete both deviations and investigations · Must be comfortable with working with investigators on completing deviations and investigations from a c ...
-
et8r - Junior Physical Interface Responsible
Found in: Orion Innovations US - 2 days ago
Oceanic Ventures Ten Mile Run, NJ, United States FreelanceAirbus Helicopters is seeking a Junior Physical Interface Responsible (d/f/m) for our location in Ten Mile Run, NJ. Our Physical Integration & Standardisation Activities Department is an engineering function that works with various departments within the company, such as Research ...
-
Technical Services Engineer
Found in: Lensa US 4 C2 - 6 days ago
Mauser Packaging Solutions East Brunswick, United StatesEngineer, Technical Services · Job Summary · The position develops and maintains standardized processes and procedures as they relate to operation of packaging testing lab. The lab is a full-scale performance testing facility for UN rated packaging (steel, fiber and poly drum ...
-
Field Service Engineer II chevron_right
Found in: Lensa US 4 C2 - 11 hours ago
Emsar Jamesburg, United StatesJob Details · Level : Experienced · Job Location : Undisclosed · Salary Range : Undisclosed · Job Shift : Day · Job Category : Skilled Labor - Trades · Description · Equipment Management Service and Repair – EMSAR, headquartered in Austin, Texas, is a fast-growing national tech ...
-
Field Service Engineer
Found in: Lensa US 4 C2 - 20 hours ago
Lighthouse Lab Services New Brunswick, United StatesLighthouse Lab Services is excited to represent a laboratory in Miami, Florida that is looking for a Field Service Engineer to add to their growing team · Position Overview · • Respond to and facilitate the repair of diagnostic equipment that has failed at the customer site · • P ...
-
Resident Service Engineer
Found in: Jooble US O L C2 - 4 hours ago
RWJBarnabas Health New Brunswick, NJ, United StatesRSE2 demonstrates confidence using tools and test equipment to perform preventative maintenance and service on radiological equipment. · Minimum AAS degree in Biomedical Engineering, Electronics Engineering Technology or equivalent work/military experience on radiology equipment ...
-
Field Service Engineer
Found in: ZipRecruiter Test10S US C2 - 8 hours ago
Lighthouse Lab Services New Brunswick, United StatesJob Description · Job DescriptionLighthouse Lab Services is excited to represent a laboratory in New Brunswick, NJ that is looking for a Field Service Engineer to add to their growing team · Position Overview · •Respond to and facilitate the repair of diagnostic equipment that h ...
-
Radiology Service Engineer II
Found in: ATTB US A2 - 4 hours ago
RWJBarnabas Health New Brunswick, NJ, United StatesJob Overview: · Reports to assigned work locations as required to meet organizational needs. RSE2 demonstrates confidence using tools and test equipment to perform preventative maintenance and service on radiological equipment. · Qualifications: · Required: · Minimum AAS degree i ...
-
Engineering Services
Found in: Lensa US 4 C2 - 1 day ago
Top Tier Reps LLC Freehold, United StatesKey Responsibilities · Leadership and Direction · Receive broad guidance relating to overall key objectives, critical issues, new concepts, and policy matters and broad parameters for execution. · Receive direction as needed, and especially on highly complex assignments. · Ind ...
-
Engineering Services
Found in: ZipRecruiter Test10S US C2 - 8 hours ago
Top Tier Reps LLC Freehold, United StatesJob Description · Job DescriptionKey Responsibilities · Leadership and DirectionReceive broad guidance relating to overall key objectives, critical issues, new concepts, and policy matters and broad parameters for execution. Receive direction as needed, and especially on highly c ...
-
Radiology Service Engineer II
Found in: Lensa US 4 C2 - 4 days ago
RWJBarnabas Health New Brunswick, United StatesRadiology Service Engineer II (FT)- Imaging Services- New Brunswick, NJ · Req #: · Category: · Biomedical Engineering · Status: · Full-Time · Shift: · Day · Facility: · RWJBarnabas Health Corporate Services · Department: · Imaging Services · Location: · RWJ - New Brun ...
-
Radiology Service Engineer II
Found in: Lensa US 4 C2 - 20 hours ago
RWJ Barnabas New Brunswick, United StatesJob Summary · Reports to assigned work locations as required to meet organizational needs. RSE2 demonstrates confidence using tools and test equipment to perform preventative maintenance and service on radiological equipment. Ensures radiological equipment meets manufacture speci ...
-
Radiology Service Engineer II
Found in: Lensa US 4 C2 - 2 days ago
RWJBarnabas Health Corporate Services New Brunswick, United StatesJob Overview: · Reports to assigned work locations as required to meet organizational needs. RSE2 demonstrates confidence using tools and test equipment to perform preventative maintenance and service on radiological equipment. · Qualifications: · Required: · Minimum AAS degree i ...
-
Field Service Engineer II
Found in: Lensa US 4 C2 - 1 day ago
Leica Biosystems New Brunswick, United StatesLeica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings h ...
-
Field Service Engineer II
Found in: Lensa US 4 C2 - 1 day ago
Danaher Corporation New Brunswick, United StatesLeica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings h ...
-
Service Mesh Engineer
Found in: Lensa US 4 C2 - 2 days ago
Apex Systems Pennington, United StatesApex Systems combines with parent company ASGN Inc. to make it the 2nd largest IT staffing agency in the country. · Apex has an opportunity for a Service MeshEngineer. If interested in discussing the position further, please send an MS Word version of your resume to Corey Smith ...
-
Engineering and Property Services Coop
Found in: beBee S2 US - 1 week ago
Johnson & Johnson New Brunswick, United States Full timeAt Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and aff ...
Technical Services Engineer - Monmouth Junction, United States - Tris Pharma
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 addressing 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 our team members set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.
We have an opening in our Monmouth Junction, NJ facility for an experienced Technical Services (TS) Engineer I.
The TS Engineer I provides direct validation support to pharmaceutical development and manufacturing operations.
The incumbent performs both routine and more complex validation activities accurately and completes appropriate documentation fully and compliantly in accordance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) requirements.
Special knowledge or skills needed and/or licenses or certifications required
Bachelors degree in science or technology related field (Engineering, Chemistry, Pharmacy, etc.) and minimum 2 years experience in a validation, technical services, manufacturing operations, product development or related field in a pharmaceutical or biotechnology related industry
OR Masters degree in science or technology related discipline (Engineering, Chemistry, Pharmacy, Biology, etc.)
Physical requirements
Office/Manufacturing based position
Ability to use Personal Protective Equipment (PPE)
Ability to stand for extended periods
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-onsite
Technical Services Engineer professionals in Monmouth Junction
-
Jarema Kraus
Jarema N. Kraus (DOC) · 1607 Mulberry Ct. o Monmouth Jct., NJ 08852 o (732) 694-0530 (732) 274-206 ...
-
Nikita Shah
Customer service officer