- Adhere to all company and cGMP procedures as well as applicable safety regulations.
- Author change controls, SOPs and protocols.
- Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards
- Responsible for confirming all communicated validation plans to applicable management
- Provides technical assistance in the form of rationales or validation studies
- Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.
- Troubleshoots and resolves issues as needed
- Manage multiple projects with competing deadlines
- Manage external resources to complete tasks outside SPI's capabilities
- Manage approvers of documents and procedures and ensure timely closure of tasks
- Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee
- Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.
- Source and procure equipment, supplies and other materials as needed.
- Develop and maintain cross-functional relationships
- Bachelor of Science in Engineering or related field preferred.
- Experience in pharmaceutical, medical device, or biotechnology industries, particularly in validation, QA, or R&D roles.
- Proficiency in FDA regulations, GMP/GLP/GCP, and Lean Manufacturing principles.
- In-depth understanding of pharmaceutical plant operations.
- Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the Job
- Experience authoring change controls in Trackwise or other quality management system
- Experience authoring SOPs in MasterControl or other document management system
- Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions.
- People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.
- Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently
- Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
- Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.
- Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes
- Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds
- Climb ladders and work in high, precarious places up to elevations of 75 feet
- Regularly exposed to work near moving mechanical parts
- Exposed to wet or humid conditions
- Exposed to outdoor weather conditions
- Regularly exposed to high noise environments
- Exposed to extremely dusty environments
- Exposed to chemicals used in the manufacturing process
-
Validation Engineer
3 weeks ago
PEAK Technical Staffing USA Ramsey, United StatesP-DPD-001 · Our client in Ramsey, NJ is hiring a Validation Engineer that will be responsible for preperation of validation protocols (IQ/OQ) and commissioning documents for their equipment and control systems. This role will be 100% onsite. · JOB RESPONSIBILITES INCLUDE BUT NO ...
-
Validation Engineer
2 weeks ago
Glatt Group Ramsey, United StatesJob description · Essential Job Function: · 1. Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential. · 2. Experience is required ...
-
Validation Engineer
3 weeks ago
Scientific Search Ramsey, United StatesJob Title: Validation Engineer · Location: · Ramsey, NJ · Position Overview · Join our team as a Validation Engineer, where you will spearhead the development and execution of validation protocols (IQ and OQ) and play a crucial role in ensuring the compliance and efficacy of ...
-
Validation Engineer
3 weeks ago
Glatt Group Ramsey, United StatesJob description · Essential Job Function: · 1. Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential. · 2. Experience is requi ...
-
Validation Engineer
1 week ago
PEAK Technical Staffing USA Ramsey, United StatesOur client in Ramsey, NJ is hiring a Validation Engineer that will be responsible for preperation of validation protocols (IQ/OQ) and commissioning documents for their equipment and control systems. This role will be 100% onsite. · JOB RESPONSIBILITES INCLUDE BUT NOT LIMITED TO: ...
-
Validation Engineer
3 weeks ago
ContractTECH Inc Ramsey, United StatesOur client in Ramsey, NJ is hiring a Validation Engineer that will be responsible for preperation of validation protocols (IQ/OQ) and commissioning documents for their equipment and control systems. This role will be 100% onsite. · JOB RESPONSIBILITES INCLUDE BUT NOT LIMITED TO: ...
-
Product Validation Engineering Technician
1 week ago
Cummins New York, United States**Product Validation Engineering Technician 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinkers to ...
-
Product Validation Engineering Technician
2 weeks ago
Cummins New York, United States**Product Validation Engineering Technician · - 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinker ...
-
Product Validation Engineering Technician
2 days ago
Cummins New York, United States**Product Validation Engineering Technician - System Performance 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most i ...
-
Validation Engineer
3 weeks ago
Executive Alliance Paramus, United StatesJob Description · Job Description · Our client is a leading manufacturer of specialized machinery and equipment for the pharmaceutical and medical device industries. They are seeking a skilled Validation Engineer to join their team. · **PLEASE NOTE THIS IS NOT A C2C ROLE** · ...
-
Validation Engineer
5 days ago
Executive Alliance Paramus, United StatesSalary : $ $110000 · Responsibilities: · Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. · Reading and interpreting electric and pneumatic controls, technical design documents, and PLC code. · Travel ...
-
Validation Engineer
1 week ago
Executive Alliance Paramus, United StatesSalary : $ $110000 · Responsibilities: · Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. · Reading and interpreting electric and pneumatic controls, technical design documents, and PLC code. · Trave ...
-
Validation Engineer
3 weeks ago
eTeam New York, United StatesJob Title: Validation Engineer · Location: Athens, GA · Duration: 06 months · Duties: · Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and ware ...
-
Validation Engineer
1 week ago
Insight Global Parsippany, United StatesDay to Day: · Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality ...
-
Validation Engineer
1 week ago
Acara Solutions, An Aleron Company New Jersey, United StatesAcara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
-
Validation Engineer
3 weeks ago
Glatt Group New York, United StatesJob description · Essential Job Function: · 1. Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential. · 2. Experience is required ...
-
Validation Engineer
3 weeks ago
Ascendum KPS New York, United StatesJob description · Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement. · Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing proc ...
-
Validation Engineer
3 weeks ago
HCLTech New York, United StatesJob Description : · 1) 7 to 9 years of Experience in Software verification and testing activities. · 2) Design, develop, and execute comprehensive test plans, test protocols and test cases for verification and validation of embedded software. · 3) Collaborate with cross-function ...
-
Validation Engineer
2 weeks ago
Aequor Inc New York, United StatesPosition: Validation Engineer · Location: Summit NJ 07901 · Duration: 6+ months (possibility of extension for the right candidate depending on performance) · Pay rate: $78.66/ hour on W2 · 100% onsite · Highly preferred cell therapy equipment commissioning qualification. · Mus ...
-
Validation Engineer
6 days ago
Weiss-Aug Group Fairfield, United StatesJob Type · Full-time · Description · Weiss-Aug Group is an internationally recognized leader in precision metal stamping, injection molding, value-added assembly solutions and tooling. · Our Surgical Products Division serves the medical device industry and has created special ...
Engineer I, Validation - Spring Valley, United States - Strides Pharma Inc
Description
Job Description
Job DescriptionJob Summary: The Validation Engineer, a pivotal member of the Engineering Department, operates both independently and collaboratively to author and execute IQ/OQ/PQ protocols, engineering studies, and facility qualifications. Ensuring adherence to manufacturing specifications, Good Manufacturing Practices (GMP), and national standards, they undertake engineering projects and troubleshoot issues, fostering collaboration across departments for seamless operations.
Key Accountabilities:
Engineering Services:
Project Management:
Qualifications:
Education & Experience:
Knowledge:
Skills & Abilities:
Physical Requirements:
