- Ensuring new equipment is appropriately designed/qualified and existing processes runs in a compliant manner through equipment lifecycle.
- Owns and manages changes to the process equipment to maintain equipment in a validated state. Potentially take on a global role in ensuring consistency across manufacturing sites.
- Investigating any equipment or process deviations and developing corrective actions to prevent reoccurrences.
- Participate in all FDA and internal audits of the manufacturing facilities and process equipment as SME and respond to any observations received.
- Actively monitor equipment performance in compliance with site reliability and maintenance strategies. Applies knowledge of engineering principles and best practices to ensure robust solutions.
- Provide mentorship to other process engineers.
- Assist to provide SME support on capital related projects. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).
- Help evaluate new technologies and equipment platforms for manufacturing.
- Providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site. Equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers bio-safety cabinets, offline bench-top instruments or facility/utility systems.
- Assists with the translation of current and future processes into the facility and utility equipment requirements at a manufacturing site.
- B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 2 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations; OR 6 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
- Excellent oral and technical writing and communication skills.
- Experience working in a team environment, with good organizational skills.
- Experience in development, automation, and manufacture of gene therapy products, medical devices, instruments OR biotechnology.
- Strong foundation FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
- Developing professional expertise, applies company policies and procedures with ability to work on problems of moderate scope where analysis of situations or data.
- Exercises judgment within defined procedures and practices to determine appropriate action and builds productive internal/external working relationships.
-
Process Engineer
2 days ago
Insight Global Durham, United StatesA large manufacturing customer of ours is seeking a Sr. Process Engineer to join their team in Durham, NC. - Solving complex problems while working with manufacturing departments, contractors, suppliers, and customers considering the implications of issues such as cost, safety an ...
-
Process Engineer
2 days ago
374Water Systems Inc Durham, United StatesJob Description · Job DescriptionLocation: This is a remote position with 80% travel to customer sites. · ARE YOU READY TO BE A PIONEER IN THE WATER INDUSTRY? · At 374Water, our mission is to preserve a clean and healthy environment that sustains life. Our revolutionary AirSCWO ...
-
Process Engineer
3 weeks ago
The Fountain Group Durham, United StatesThe Fountain Group is currently seeking a Process Engineer for a prominent client of ours. This position is located in Durham, NC. Details for the position are as follows: · Pay Range: $35-45/hr · Temp to perm position based on performance · 100% onsite · Job Descriptio ...
-
Wafer Processing Engineer
2 weeks ago
Micross Durham, United States PermanentSummary: · The position will primarily focus on learning and supporting wafer processing steps required to further develop and build IR emitter pixels for the IRSP program area. This includes sputter depositions, reactive sputter depositions, ion milling, RIE, descums, ultrasoni ...
-
Wafer Processing Engineer
3 weeks ago
Micross Components Durham, United StatesJob Description · Job DescriptionMicross Advanced Interconnect Technology is seeking a knowledgeable, self-motivated physical science or engineering student for an internship with our Process Engineering team. The internship will require extensive hands-on wafer processing in our ...
-
Manufacturing Process Engineer
3 weeks ago
Biomason, Inc. Durham, United StatesJob Description · Job DescriptionCompany Overview: Are you a results-driven problem-solver, eager to positively change the world? Do you believe that climate change is the biggest issue facing us today? Then the Biomason team needs you Biomason is leading the global transition to ...
-
Process/Validation Engineer
1 week ago
Katalyst Healthcares and Life Sciences Durham, United StatesResponsibilities: Validation Planning: Develop and implement validation strategies, including process, equipment, and cleaning validation, in compliance with FDA and international regulatory guidelines. · Validation Protocol Design: Create and execute validation protocols (IQ, OQ ...
-
Process Sustaining Engineer
3 days ago
Cree Durham, United StatesGeneral responsibilities: · Own manufacturing processes for wafer preparation processes ensuring capable & in control: · Define process control methods for detecting process variations. Including creation and monitoring appropriate process parameter control charts. Implement ra ...
-
Process Engineer
3 weeks ago
Cubic Durham, United StatesBusiness Unit:Cubic DefenseCompany Details:When you join Cubic, you become part of a company that creates and delivers technology solutions in transportation to make people's lives easier by simplifying their daily journeys, and defense capabilities to help promote mission succes ...
-
Process Engineer
3 weeks ago
Cubic Durham, United StatesCubic | Nuvotronics Design for Manufacturing (DFM) Team is a multidisciplinary team of engineers, designers, and technicians who translate designs from our electrical engineering design team into buildable products. As a Process Engineer within this Process Engineer, Engineer, El ...
-
Process Engineer
2 weeks ago
Cubic Durham, United StatesBusiness Unit: · Cubic Defense · Company Details: · When you join Cubic, you become part of a company that creates and delivers technology solutions in transportation to make people's lives easier by simplifying their daily journeys, and defense capabilities to help promote mi ...
-
Process Engineer
3 weeks ago
Wolfspeed Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-ori ...
-
Senior MSAT Process Engineer
2 weeks ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and tran ...
-
Process Engineer
2 weeks ago
Micross Durham, United StatesSummary:We are seeking a knowledgeable, self-motivated individual for our growing operations team which will support processing in a dynamic production and R&D environment. This position will focus on supporting advanced packaging processing and process development, for, but not ...
-
Process Engineer
2 weeks ago
Micross Durham, United StatesSummary: · We are seeking a knowledgeable, self-motivated individual for our growing operations team which will support processing in a dynamic production and R&D environment. This position will focus on supporting advanced packaging processing and process development, for, but ...
-
Automation AND Process Control Engineer
3 days ago
Insight Global Durham, United StatesSummary: · Design, specify, implement, and program advanced plant process control and automation systems from the ground up to optimize safety, quality, yield, and availability. · Work cooperatively and effectively with a multidisciplinary engineering team to deploy cutting-edge ...
-
Process Engineer II
3 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Process Validation Engineer
3 weeks ago
Katalyst HealthCares & Life Sciences Durham, United StatesResponsibilities: Develop and execute process validation protocols and reports in accordance with regulatory requirements and industry best practices. · Perform risk assessments and gap analyses to identify areas for process improvement and ensure the reliability of manufacturi ...
-
Process Engineer Sustaining
4 weeks ago
Cree Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-ori ...
-
Process Engineering Technician
2 weeks ago
Volt Durham, United StatesWE BRING YOU TOMORROW'S OPPORTUNITY, TODAY · Volt is hiring a Process Engineering Technician to work onsite for our client in Durham, NC in a contract to hire opportunity. · The Process Engineering Technician will be responsible for maintaining and enhancing equipment and proce ...
Process Engineer II - Durham, United States - Novartis Group Companies
Description
Job Description Summary
The Process Engineer II is responsible for providing engineering, validation, and maintenance support to the process manufacturing equipment, facility, and utilities at a site.Job Description
Responsibilities:
Requirements:
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:
The pay range for this position at commencement of employment is expected to be between $80,000 and $120,000 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life
Handbook.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$80, $120,000.00Skills Desired
Api (Application Programming Interface), Api (Application Programming Interface), Automation Technology, Back-End Development, Business Continuity, Change Controls, Chemistry, Design Development, Electronic Components, General Hse Knowledge , Including Gdp, Java, Knowledge Of Capa, Knowledge Of Gmp, Kubernetes, Managing Performance Improvement, Manufacturing Production, Mathematical Optimization, Project Commissioning, Project Engineering, Project Implementations, , Risk Management, Root Cause Analysis (RCA), Scrum (Programming Methodology) {+ 2 more}
