Principal Process Engineer (Pharma)
Process engineer job in Durham, NC
Requirements:
Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
10+ years of experience in bioprocess engineering within the biotech or biopharmaceutical industry.
Pluses:
Master's Degree in related field.
Job Description:
Principal Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations. As a Principal Process Engineer, you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Upstream Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of process equipment.
Key Responsibilities:
You will support equipment commissioning and qualification activities related to new or modified processes.
Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.
Act the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities ensuring proper installation, qualification, and maintenance of these systems.
Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment. As the project lead you will ensure on time delivery, compliance with project requirements, and project budget.
Lead the development, scale-up, and optimization of upstream (cell culture, fermentation) and/or downstream (purification, filtration) processes for biologics or advanced therapies
Design and execute experiments to improve process robustness, yield, and product quality
Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams to ensure seamless tech transfer and GMP compliance
Author and review process documentation including SOPs, and Engineering Studies protocols
Serve as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and audits
Evaluate and implement new technologies (e.g., single-use systems, PAT tools, continuous processing) to enhance scalability and efficiency
Support capital projects including facility design, equipment selection, and commissioning
Lead risk assessments, and root cause investigations for process deviations
Communicate with other KBI sites for problem solving and consistency of processes through the organization.
Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.
You will perform facility fit activities for various production scenarios.
You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.
The ability to manage multiple concurrent projects and resources.
Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
Providing technical support for equipment modifications, deviations, change controls, and CAPAs.
Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.
Manufacturing Project Engineer
Process engineer job in Holly Springs, NC
Position involves support of senior staff in the initiation, design, and delivery of manufacturing projects, particularly for facilities-related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for facilities system, perform quality and overall facilities walkdowns. Perform field evaluations of existing systems and provide engineering design recommendations.
Responsibilities
Provide support to Facilities Senior Manager on various ongoing activities, including new projects
Accountable for walkdowns and punch list resolution
Daily responsibilities will vary based on the need of the business; it can be from maintenance operation to punch lists resolution.
Required Skills
self-starter
Ability to communicate effectively
Ability to manage tasks to completion
Experience with facilities management and projects in a biotech/pharmaceutical manufacturing environment is a must
Preferred Skills
Masters degree
OR
Bachelors degree and 2 years of experience
OR
Associates degree and 6 years of experience
OR
High school diploma / GED and 8 years of experience
Manufacturing Engineering Supervisor
Process engineer job in Raleigh, NC
Salary: $80-$95/k
DIRECT HIRE
This position is responsible for developing and executing plans for optimizing process control and instrumentation systems throughout the plant. This position will provide technical support for a wide variety of instrumentation and control equipment. The position will drive automation strategy, manage capital and projects improvement projects, and provide technical leadership in troubleshooting and continuous improvement initiatives.
Essential Functions & Responsibilities:
Manage, mentor, and develop technicians.
Set clear objectives, priorities, and performance expectations for the team.
Foster a culture of safety, quality, and continuous improvement.
Oversee design, commissioning, and validation of automation systems.
Develop and maintain site automation standards, specifications, and documentation.
Lead programming and troubleshooting for distributed controls systems and PLCs.
Develop and review electrical and other drawings in support of plant processes.
Direct the preventive maintenance, calibration, and troubleshooting of process instrumentation in compliance with GMP and regulatory requirements.
Support and participate in internal and external audits, providing technical expertise and documentation as required.
Drive root cause analysis and corrective/preventive actions (CAPAs) for automation and instrumentation-related deviations.
Identify and implement opportunities for process optimization, energy savings, and enhanced reliability.
Education, Experience, and/or Skill:
Bachelor's degree in electrical Engineering, or related field required
Minimum 8 years of automation engineering experience in a GMP-regulated environment
At least 2-5 years of direct people management experience
Experience in programming, maintaining and troubleshooting Distributed Control Systems
Strong background in standard PC applications
Strong project management skills
Knowledge in computer validation
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
Process Engineer
Process engineer job in Cary, NC
Our Cary, NC office is looking to add a Process Engineer I. This role is an entry level role for recent Chemical Engineering graduates. This role will contribute to the creation of design documents to support the Design Deliverables Matrix. Common work products will include generation of PFDs, P&IDs, Process Lists, and Equipment Specifications. In this position, you will work closely with CAD Designers to ensure successful generation of P&IDs, and more experienced engineers for guidance and direction on day-to-day activities and other work packages. The Process Engineer I must have a strong desire to learn new concepts relating to the unit operations common in a Chemical Engineering curriculum, especially as they relate to the Life Sciences field.
Our clients are primarily in the Pharmaceutical and Life Science sectors.
Key Responsibilities:
Develop P&IDs based on direction from more experienced engineers, submit drawings to CAD, and complete back-check process ensuring drawing accuracy.
Develop block flow and process flow diagrams based on direction from more experienced engineers.
Leverage department standards, generate project specific Process Specifications.
Generate vendor bid tabs from equipment specifications and complete technical bid analysis based on vendor quotations.
Evaluate process equipment utility requirements from vendor data and complete utility system capacity studies based on this and site data.
Perform basic process calculations including pump sizing, hydraulic/pipe flow, and heat transfer.
Scribe for Process Hazard and cGMP Regulatory Review studies.
Complete field surveys and P&ID walkdowns, document findings in the form of field reports.
Deliver complete and accurate design documents that have been thoroughly backchecked for review and approval by a Senior Engineer.
Attend relevant design and client meetings to gain a better understanding of the project and design work required, asking questions of the discipline leads as necessary.
Develop and present content to small groups in support of department goals and development activities.
Skills & Qualifications
Bachelor's degree, Chemical Engineering preferred. Mechanical Engineering and Biomedical Engineering degrees may also be suitable.
Ability to work independently and as part of a cross-functional team, at times with remote locations, possible.
Maintain excellent attention to detail, possess organizational, analytical, oral and written communication skills
Ability to multitask, establish priorities, and meet deadlines.
The Company
DPS Group, Inc. is proudly part of the Arcadis Group of Companies and is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
#LI-SM1
Principal Process Engineer - API + OSD
Process engineer job in Raleigh, NC
About Us:
BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.
:
Job Description
Who You'll Work With
You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.
When you join Design Group as a Principal Process Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world's leading companies solve their most difficult problems. You will join our Architecture/Engineering Process Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.
What You'll Do
The Principal Process Engineer role is a key member of the Life Science Commercial Team with responsibilities beginning with initial client contact, developing early stakeholder (client) alignment based on relationships built on technical competency, proactive client engagement and development of innovative solution. Principal will lead front end design programming for API and/or OSD processes requiring site survey, space programming and equipment evaluation/selection, economic analysis/justification, risk assessments, and regulatory impact reviews. In addition to working on front end phases, you will be expected and responsible for performing technical business development active, which would include:
Participating in DG capabilities presentations to clients
Contributing to proposal development
Authoring publications and white papers
Presenting multiple times per year at industry conferences or networking events
Responsible as leading expert for Active Pharmaceutical Ingredients (APIs) and/or Oral Solid Dose (OSD) processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, recognized industry expert through published/presented thought leadership and for launching and nurturing lifecycle client programs.
Prior responsible charge expertise developing API and/or OSD process operations by defining concepts, generating client engagement/alignment, evaluating existing processes/operations, defining scale/modality appropriate solutions, aligning integration approach, and providing the qualification strategy for both traditional processing methods and emerging technologies to align industry standards with regulatory guidance.
Passionate industry expert with outgoing personality that has experience presenting innovative concepts to other thought leaders, possessing the ability to generate interest, facilitate adoption, and create advocacy for emerging concepts while being cognizant of disruptive technologies and trends that influence investment decisions.
cGMP & Regulatory Compliance: Deep understanding of FDA/EMA guidelines (like USP , Annex 1) and managing inspections/deviations.
API Process Development & Engineering:
Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial-scale manufacturing
Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
Establish process parameters, control strategies, and manufacturing specifications for API production
OSD Process Development & Engineering:
Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial-scale manufacturing
Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
Establish process parameters, control strategies, and manufacturing specifications for API production
Process Development & Transfer: Leading tech transfers, optimizing processes, and developing Master Batch Records (MBRs) and SOPs.
Quality & Contamination Control: Overseeing environmental monitoring, media fills, gowning, cleaning, and root cause analysis for contamination events.
Training & Leadership: Developing and delivering technical training, acting as a technical lead, and providing expert support.
Executes process system engineering from conceptual/planning to final/detail design phase on a wide range of projects from system enhancements or unit operation optimization through all-new greenfield construction.
Works closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation to ensure systems are designed in accordance with current Good Manufacturing Practices.
Understanding and development of process construction documents including piping & instrument diagrams (P&IDs), equipment general arrangement drawings, piping plans inclusive of orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), scopes of work, etc.
Interfaces with OEM's/vendors as needed to accomplish equipment sizing and selection.
Develops project scopes and assists with preparation of proposals for engineering/design services as well as complete constructed solutions.
Stays abreast of new and emerging technologies, and current Good Manufacturing Practices
Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
What You'll Bring
Minimum of 20 years of pharmaceutical and biologics process system engineering/design experience.
Experience in proposal generation and supporting business development.
Front-end/feasibility study experience.
Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
Working knowledge of process definition means and methods including identifying process unit operations required
Experience with FDA and EMA regulatory standards.
Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients.
Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic). Familiarity with 3D modeling, computer-based hydraulic analysis and process simulation software skills are considered a plus.
Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.
Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Principal Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.
The approximate pay range for this position is $250K - $275K. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.
#LI-JF1
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company:
Design Group
Auto-ApplyPrincipal Process Engineer
Process engineer job in Durham, NC
Principal Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations.
As a Principal Process Engineer, you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Upstream Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of process equipment.
Key Responsibilities
You will support equipment commissioning and qualification activities related to new or modified processes.
Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.
Act the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities ensuring proper installation, qualification, and maintenance of these systems.
Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment. As the project lead you will ensure on time delivery, compliance with project requirements, and project budget.
Lead the development, scale-up, and optimization of upstream (cell culture, fermentation) and/or downstream (purification, filtration) processes for biologics or advanced therapies
Design and execute experiments to improve process robustness, yield, and product quality
Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams to ensure seamless tech transfer and GMP compliance
Author and review process documentation including SOPs, and Engineering Studies protocols
Serve as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and audits
Evaluate and implement new technologies (e.g., single-use systems, PAT tools, continuous processing) to enhance scalability and efficiency
Support capital projects including facility design, equipment selection, and commissioning
Lead risk assessments, and root cause investigations for process deviations
Communicate with other KBI sites for problem solving and consistency of processes through the organization.
Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.
You will perform facility fit activities for various production scenarios.
You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.
The ability to manage multiple concurrent projects and resources.
Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
Providing technical support for equipment modifications, deviations, change controls, and CAPAs.
Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.
Requirements:
Bachelor's, Master's, in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
10+ years of experience in bioprocess engineering within the biotech or biopharmaceutical industry.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Auto-ApplyPrincipal Process Engineer
Process engineer job in Durham, NC
Company 8 Rivers is a Durham, NC firm focused on the invention, development, and commercialization of sustainable, infrastructure-scale solutions to global problems through impactful technologies. The company maintains the agility, creativity, and fast-paced environment of a start-up, while partnering with large, industry-leading companies to develop and deploy those technologies. Our process enables us to innovate in industrial fields that are lacking in creative disruption. 8 Rivers has demonstrated expertise in generating and commercializing large-scale, meaningful solutions to some of the most challenging problems facing the world today and across a variety of industries in the clean energy, carbon capture, and clean fuels sectors.
The company innovates widely in adjacent markets in the clean tech space. Some of our marquee technologies include the Allam-Fetvedt Cycle - a zero-emission power production system that enables low-cost power production with inherent carbon capture, 8RH2 - our innovative clean hydrogen technology utilizing CO2 convective reforming to achieve 99% carbon capture.
Opportunity
We're seeking a Principal Process Engineer to design, implement, and optimize industrial processes. This person will play a critical role in ensuring that the process technology from concept through detailed design and production operations meets the intended objectives in a safe, efficient, and a cost-effective manner.
Responsibilities
Process Design and Development: Develop, modify or review process flow diagrams (PFDs), heat and material balances (H&MBs)
Technical Analysis and Evaluation: Conduct technical analysis, simulations, calculations to evaluate process performance, efficiency, and safety. Use engineering software tools to model and optimize process systems.
Equipment Selection and Specification: Select and specify process requirements for equipment, such as reactors, heat exchangers, pumps, compressors, and separators, ensuring compatibility with process requirements, codes, and standards. Review detailed equipment specifications during 3rd party conducted engineering studies.
Process Optimization and Troubleshooting: Identify opportunities for process optimization to simplify, derisk, create flexibility, improve efficiency/reduce costs, and/or enhance performance in another manner. Analyze process-related design issues and offer creative solutions to resolve problems.
Technical Leadership and Guidance: Providing technical leadership and expertise to the internal and external stakeholders involved with a given technology or project. This involves mentoring junior engineers, sharing best practices, and contributing to the development of process engineering standards and procedures.
Project Coordination and Collaboration: Collaborate with multidisciplinary project teams, including engineers, designers, and project managers, to ensure that process engineering requirements are integrated into overall project objectives and deliverables. Administrative tasks as required to self-organize workstreams.
Documentation and Reporting: Review process engineering documentation, including design specifications, technical reports, calculations, and drawings. Ensure documentation is accurate, thorough, and compliant with project requirements and standards.
Research and Development Support: Collaborating with R&D departments to support the development of adaptation of existing technology or develop new features/next generation of existing technologies. This may involve designing and conducting experiments or R&D efforts, analyzing data, and integrating new technologies into existing processes. This also involves technical support of intellectual property management.
Technical Decision Making: Review information and analysis prepared by external engineering firms or internal engineers and determine best path forward to meet project and/or development objectives within existing set of constraints.
Qualifications
Requires a bachelor's or master's degree in chemical engineering.
12 or more years of professional experience with a minimum of 10 years working in relevant industries such as syngas generation/processing/ cleanup, hydrogen, /ammonia, and/or oil & gas with exposure to hydrogen, syngas, gas processing, and reforming, and/or power production with exposure to point source capture, and/or clean energy technologies.
Experience in process design development & review of PFDs, H&MBs, P&IDs, performing other engineering calculations & analysis, and participating in HAZOPs/PHA.
Proven track record of sound technical decision making.
Experience with technical support of capital projects at different development stages (i.e. feasibility study, FEED through construction & commissioning).
Experience performing process modeling via simulation software like ASPEN Plus or HYSYS.
Knowledge and experience with interpreting and applying international codes and standards for design and analysis of equipment such as API, ASME, NFPA, and ANSI.
Strong written and verbal communication skills including ability to succinctly summarize complex technical information for a broad audience of key stakeholders across multiple departments and functions.
Strong organizational skills including attention to detail.
Preferred Skills and Abilities
Knowledge or experience with Allam-Fedtvedt Cycle (AFC).
Experience with technical support of capital projects greater than $50M.
Experience as an onsite (resident) engineer supporting daily operations.
Experience in chemical, industrial gases, power generation and/or clean energy industry & technologies.
Willingness to mentor & coach team members.
Process Development Associate (Attribute Sciences)
Process engineer job in Holly Springs, NC
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Process Development Associate (Attribute Sciences)**
**What you will do**
Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.
In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
+ Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
+ Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
+ Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
+ Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
+ Execute methods, author reports and ensure safety and compliance for all activities.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
+ Associate's degree and 2 years of Process Development / Chemistry or related experience OR
+ Bachelor's degree
**Preferred Qualifications:**
+ Degree in Chemistry or related area.
+ Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
+ Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR).
+ Experience in method transfers, method validation, and method troubleshooting.
+ Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
+ Effective oral and verbal communication skills.
+ Technical writing skills and attention to details in documents.
+ A self-starter and valuable teammate.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Process Engineer
Process engineer job in Raleigh, NC
We are seeking a Process Engineer who is a highly skilled Analyst to lead the standardization and ongoing maintenance of our Machine Bill of Materials (BOM). This role requires a professional with certification in Six Sigma certification and proven expertise in process improvement. The Analyst will play a critical role in streamlining our assembly processes, driving product line standardization, and collaborating with vendors to maximize purchasing power. This position will report into our Engineering Manager at Axon.
Key Responsibilities
* Standardize and maintain BOMs: Develop, implement, and oversee standardized machine BOMs across product lines to ensure accuracy, consistency, and efficiency.
* Process improvement leadership: Apply Six Sigma methodologies to identify inefficiencies, reduce waste, and optimize assembly workflows. Work instruction development.
* Cross-functional support: Work closely with engineering, operations, and procurement teams to ensure BOM accuracy and process alignment.
* Continuous improvement culture: Champion best practices, train team members, and foster a culture of operational excellence.
* And other duties as assigned
Qualifications
* Six Sigma training/certification a plus.
* Experience with BOM management utilizing ERP inventory systems in a manufacturing or assembly environment.
* Analytical mindset with proficiency in data-driven decision-making and reporting tools.
* Collaboration and communication skills to work effectively across departments and with external partners.
* Bachelor's degree in Engineering, Supply Chain, Operations Management, or related field preferred.
What's in it for you?
There's no monopoly on innovative ideas or limits to how far you can advance with our team. We offer an open, communicative environment that fosters individual initiative. We pride ourselves in being a company where people are happy and choose to build a career.
In addition to growth opportunities, as a ProMach employee, you receive more than just a paycheck. Total compensation includes your salary, comprehensive medical/dental programs, as well as life insurance, a generous paid time off program, and a retirement savings plan with a company match. And because we understand the importance of feeling protected, there is no waiting period for benefits - you are eligible on your first day of employment!
Please note that the pay ranges listed on external job boards, outside our posting details, do not accurately reflect our internal compensation ranges.
Pro Mach, Inc. was named to the Inc. 5,000 list of the fastest growing private companies in the U.S. seven times. We continue to introduce innovative products, enter new markets, expand our global presence, and actively acquire new capabilities.
We have the rewards, opportunities, and the market strength of a large organization combined with the entrepreneurial culture of a small, fast-paced company. You will enjoy the benefits of working with a growing company that competes globally with the personal touch and feel of a smaller company where you can make an impact every day.
Curious about life at ProMach? Follow us on LinkedIn, Twitter, and Instagram!
ProMach is an Equal Opportunity Employer. Pro Mach uses E-Verify to verify employment eligibility of all new hires to work in the United States. Pro Mach is a drug-free workplace.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
RTP Semiconductor Process Engineering Intern
Process engineer job in Durham, NC
MACOM designs and manufactures semiconductor products for Data Center, Telecommunication and Industrial and Defense applications. Headquartered in Lowell, Massachusetts, MACOM has design centers and sales offices throughout North America, Europe and Asia. MACOM is certified to the ISO9001 international quality standard and ISO14001 environmental management standard.
MACOM has more than 75 years of application expertise with multiple design centers, Si, GaAs and InP fabrication, manufacturing, assembly and test, and operational facilities throughout North America, Europe, and Asia. View our facilities at ********************** In addition, MACOM offers foundry services that represents a key core competency within our business.
MACOM sells and distributes products globally via a sales channel comprised of a direct field sales force, authorized sales representatives and leading industry distributors. Our sales team is trained across all of our products to give our customers insights into our entire portfolio.
RTP Semiconductor Process Engineering Intern
Role Overview:
As a member of the process engineering team, the Process Engineering Intern will work alongside experienced engineers providing mentoring, guidance, and introductions to colleagues.
This Internship with MACOM will help the Intern to gain valuable work experience in a key discipline, build professional relationships, and take ownership of a business-critical project.
During the 12 weeks each Intern will:
> Be given an individual and well-defined project with set outcome goals
> Gain hands on experience
> Receive excellent training and ongoing supervision
> Be invited to attend an intern webinar series
> Attend networking/social events
> Attend and present at Poster Session about each Interns project successes and pitfalls
> Receive formal, written feedback
Prerequisite Skills and Experience:
* · Strong foundational knowledge of semiconductor fabrication processes and cleanroom protocols.
* · Familiarity with process control concepts and statistical analysis.
* · Excellent problem-solving skills and attention to detail.
* · Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
* · Effective communication skills, both written and verbal.
Additional Desirable Skills:
* · Hands-on experience with semiconductor process equipment or lab-based process development.
* · Experience with Statistical Process Control (SPC) tools and methodologies (e.g., control charts, Cp/Cpk analysis, DOE).
* · Basic coding or scripting skills (e.g., Python, MATLAB, or R) to support data analysis and SPC automation.
* · Familiarity with data visualization tools (e.g., JMP, Tableau, or Power BI).
* · Understanding of Design of Experiments (DOE) and root cause analysis techniques (e.g., 5 Whys, Fishbone diagrams).
* · Exposure to Six Sigma or Lean Manufacturing principles.
* Due to ITAR regulations, the candidate must be a US Citizen or Permanent Resident
Requirements:
Currently enrolled in a bachelor's or master's degree in electrical engineering, materials science, or equivalent.
EEO:
MACOM is an Equal Opportunity Employer committed to a diverse workforce. MACOM will not discriminate against any worker or job applicant on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, genetic information, veteran status, military service, marital status, or any other category protected under applicable law.
Reasonable Accommodation:
MACOM is committed to working with and providing reasonable accommodations to qualified individuals with physical and mental disabilities. If you have a disability and are in need of a reasonable accommodation with respect to any part of the application process please call *************** or email HR_*************. Provide your name, phone number and the position title and location in which you are interested, and nature of accommodation needed, and we will get back to you. We also work with current employees who request or need reasonable accommodation in order to perform the essential functions of their jobs.
Process Engineering Internship
Process engineer job in Durham, NC
Responsibilitiesarrow_right * Support Operations by identifying and resolving machine failures and suboptimal performance through data analysis, engineering studies, predictive maintenance, and root cause analysis. Apply Lean, Six Sigma, and systems thinking to methodically break down problems and craft appropriate solutions.
* Apply knowledge of industrial control systems and electromechanical systems/principles to troubleshoot and resolve ongoing machine issues
* Support all company safety objectives through modification or redesign of equipment
* Provide design and project management support to the Engineering and Maintenance Teams as needed
* Work with third parties to outsource fabrications and procure necessary parts or materials
Qualificationsarrow_right
* Candidates must hold a degree in one of the following disciplines:
* Textile Engineer
* Polymer/Chemical Engineer
* Mechanical Engineer
* Industrial Engineer
*
* Technical Skills & Experience:
* Ideal candidates will demonstrate proficiency in the following areas:
* Non-Woven Materials: Hands-on experience in the development, testing, or manufacturing of non-woven textiles.
* Polymer Science: Strong understanding of polymer properties, processing techniques, and applications in industrial or consumer products.
* Quality Control: Experience implementing and managing quality assurance protocols, including statistical process control and defect analysis.
* Data Analytics: Ability to analyze production or performance data using tools such as Excel, or specialized manufacturing analytics platforms to drive process improvements and decision-making.
Process Engineering Internship
Process engineer job in Durham, NC
* Support Operations by identifying and resolving machine failures and suboptimal performance through data analysis, engineering studies, predictive maintenance, and root cause analysis. Apply Lean, Six Sigma, and systems thinking to methodically break down problems and craft appropriate solutions.
* Apply knowledge of industrial control systems and electromechanical systems/principles to troubleshoot and resolve ongoing machine issues
* Support all company safety objectives through modification or redesign of equipment
* Provide design and project management support to the Engineering and Maintenance Teams as needed
* Work with third parties to outsource fabrications and procure necessary parts or materials
Qualificationsarrow_right
* Candidates must hold a degree in one of the following disciplines:
* Textile Engineer
* Polymer/Chemical Engineer
* Mechanical Engineer
* Industrial Engineer
*
* Technical Skills & Experience:
* Ideal candidates will demonstrate proficiency in the following areas:
* Non-Woven Materials: Hands-on experience in the development, testing, or manufacturing of non-woven textiles.
* Polymer Science: Strong understanding of polymer properties, processing techniques, and applications in industrial or consumer products.
* Quality Control: Experience implementing and managing quality assurance protocols, including statistical process control and defect analysis.
* Data Analytics: Ability to analyze production or performance data using tools such as Excel, or specialized manufacturing analytics platforms to drive process improvements and decision-making.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Quality Process Engineer
Process engineer job in Mebane, NC
Armacell provides numerous and diverse career opportunities. Add your talent to ours and make a difference around the world!
As a Quality Process Engineer, you'll play a key role in ensuring our products meet the highest quality standards - from development through manufacturing. You'll collaborate with cross-functional teams to drive continuous improvement, lead root cause analysis, and support key quality initiatives to ensure customer satisfaction.
What Armacell can offer you
Healthcare benefits including medical & prescription drug coverage, dental, vision, and mental health & wellbeing.
Financial programs such as 401(k), life insurance, short & long- term disability coverage, and opportunities for performance-based salary incentive programs
Generous paid time off including 12 holidays and at least 120 hours PTO
Training and educational resources on our personalized learning management system
Giving & volunteer opportunities, and discounts on retail products, services & experiences
Key Responsibilities
Co-lead the World Class Manufacturing (WCM) Quality Pillar (QPC).
Promote and adhere to all safety standards in lab and plant environments.
Manage document and data control processes.
Administer the PPAP (Production Part Approval Process) program as required.
Lead data-driven problem solving and root cause analysis initiatives.
Maintain the Material Review Board and manage nonconforming materials.
Track and report monthly quality performance metrics.
Monitor and improve processes related to customer satisfaction.
Lead and process corrective/preventive actions within the plant.
Serve as an internal ISO 9001:2015 auditor and support annual audits.
Conduct Gage R&R studies and capability analyses.
Understand and apply customer-specific quality requirements.
Co-lead Product Conformity Audits and maintain documentation in DCT.
Conduct annual product testing and manage customer certifications.
Oversee raw material certifications and incoming material data entry.
Coordinate outsourced testing and UL certifications.
Manage collection and shipment of sales samples.
Administer AIMS setup, label databases, and quality document systems (e.g., Qualtrax).
Support other quality projects as assigned.
Qualifications
Bachelor's degree in Engineering or Chemistry (required)
3+ years of quality assurance experience in a manufacturing setting
Strong analytical, problem-solving, and communication skills
Able to thrive in a global, cross-functional team environment
Self-motivated with the ability to manage multiple tasks in a fast-paced setting
Proficiency in Microsoft Office and quality systems
Familiarity with SPC (Statistical Process Control) and world-class manufacturing tools
Experience with rubber processing (mixing, curing, extrusion, foaming) is a plus
Proven leadership and project management capabilities
Must be authorized to work in the U.S. without sponsorship
The expected compensation range for this role is $80,000.00 -$95,000.00.
The compensation range and benefits for this position are based on a full-time schedule for a full calendar year. The salary will vary depending on your job-related skills, experience, and location. Pay increment and frequency of pay will be in accordance with employment classification and applicable laws. For part time roles, your compensation and benefits will be adjusted to reflect your hours. Benefits may be pro-rated for those who start working during the calendar year.
Armacell does not accept unsolicited resumes from individual recruiters or third-party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers or HR team. In order to provide the best experience for all stakeholders, we limit the number of agencies and recruiting vendors we partner with. If you would like to be considered for a particular search or added to our approved agency list, please complete and submit this form: *************************************
More About Us
Armacell's products significantly contribute to global energy efficiency making a difference around the world every day. With more than 3,300 employees and 25 production plants in 19 countries, the company operates two main businesses, Advanced Insulation and Engineered Foams, and generated net sales of EUR 836 million and adjusted EBITDA of EUR 155 million in 2023. Armacell focuses on insulation materials for technical equipment, high-performance foams for high-tech and lightweight applications and next generation aerogel blanket technology. For more information, please visit: *****************
We look forward to receiving your application. If you want to discover more about Armacell, take another look at our website *****************
#LI-KW1
Time Type:
Full time
Auto-ApplyProcess Engineer
Process engineer job in Sanford, NC
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Purpose and Scope:
The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small/lab scale to large/commercial scale and from external partners. The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors. This role is based in Sanford, NC.
Essential Job Responsibilities:
Provide process engineering, design, and on-going improvements for drug substance manufacturing processes
Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities
Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization
Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners
Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and
Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation
Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements
Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports
Support/lead tech transfer, equipment commissioning, training, and validation activities
Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing
Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems
Support process deviation investigations, root cause analysis, and CAPAs
Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction
Will support and demonstrate data integrity standards to ensure data of highest quality
Production Engineer
Process engineer job in Haw River, NC
What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record success. We strive to be a company that serves as a source of “power” that supports people around the world who are trying to do things based on their own initiative and that helps people expand their own potential. To this end, Honda strives to realize “the joy and freedom of mobility” by developing new technologies and an innovative approach to achieve a “zero environmental footprint.”
We are looking for qualified individuals with diverse backgrounds, experiences, continuous improvement values, and a strong work ethic to join our team.
If your goals and values align with Honda's, we want you to join our team to Bring the Future!
Job Purpose
Lead, create, and implement innovative technical activities and solutions in the areas of Mass Production, Business Plan and New Model to efficiently meet or exceed Safety, Environment, Quality, Delivery, Cost, and Morale characteristic targets.
Key Accountabilities
Effectively communicate upstream and downstream to all levels of the organization to assure common understanding and direction.
Review and analyze daily report(s) to identify safety, quality, delivery gaps and develop potential countermeasures and /or root cause analysis opportunities striving for continuous improvement.
Utilize data analysis and PDCA to lead, support, develop and justify solutions with related groups/departments for your area of responsibility to solve complex problems.
Monitor and manage equipment and processes to ensure optimal manufacturing performance and function while minimizing operating expense.
Develop capability of self, colleagues, and team through training, mentoring, and sharing of experiences in area of technical expertise and understanding.
Establish priorities and make decisions based on data analytics to most effectively accomplish business objectives.
Manage project implementation, schedule, budget and resource allocations to ensure successful completion and target achievement.
Test, evaluate, and implement new and innovative technologies to improve overall equipment and process efficiency.
Develop and manage investment and expense budgets to achieve overall cost targets.
Qualifications, Experience, and Skills
Minimum Educational Qualifications
Bachelors or Associates degree in engineering or engineering technology with relevant experience (mechanical, manufacturing, industrial or electrical, etc) with interest in manufacturing, if no degree 6 years of experience required
Minimum Experience
Mfg. co-op experience preferred but not required
Decisions Expected Working Conditions
Work in production environment requiring PPE and lockout in manufacturing operations
Manufacturing environment with the potential of working near hydraulic oils, cutting lubricants, ferrous and aluminum materials
Work in production environment requiring PPE and lockout in manufacturing operations
Working near oils, cutting lubricants
Hands-on investigation and troubleshooting within equipment to countermeasure issues and to determine improvement activity
Working with hand/power tools, quality gauging and instrumentation
50% office environment/ 50% manufacturing lineside activity
Possible weekend or off-shift support as necessary
10-15 hours overtime per week
Possible weekend or off-shift support as necessary
Travel 5% (domestic & international)
What differentiates Honda and make us an employer of choice?
Total Rewards:
• Competitive Base Salary (pay will be based on several variables that include, but not limited to geographic location, work experience, etc.)
• Paid Overtime
• Regional Bonus (when applicable)
• Industry-leading Benefit Plans (Medical, Dental, Vision, Rx)
• Paid time off, including vacation, holidays, shutdown
• Company Paid Short-Term and Long-Term Disability
• 401K Plan with company match + additional contribution
• Relocation assistance (if eligible)
Career Growth:
• Advancement Opportunities
• Career Mobility
• Education Reimbursement for Continued Learning
• Training and Development programs
Additional Offerings:
• Tuition Assistance & Student Loan Repayment
• Lifestyle Account
• Childcare Reimbursement Account
• Elder Care Support
• Wellbeing Program
• Community Service and Engagement Programs
• Product Programs
• Free Drinks Onsite
Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.
In-Process Quality Engineer - 2nd Shift
Process engineer job in Raleigh, NC
Apply now " Job Type: Long-term / Regular At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.
Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.
WHAT WE ARE LOOKING FOR
The In-Process Quality Engineer is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance to Covidien requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Supports team members to insure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives. This is a second shift role.
YOUR ROLE
* Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
* Perform required QA inspections; i.e. Sample defect detection
* Ability to participate in internal audits, as requested.
* Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.
* Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
* Assist personnel in the generation of operations/packaging area related exceptions
* Have the ability to support minor exceptions and support phase II manufacturing investigations
* Attend daily operations staff communication meetings
* Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling
* Team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as, area inspections pre/post activity.
* Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
* Ability to support the QA label release functions on an as needed basis.
Department Specific/ Non-Essential Functions:
* Work safely in accordance with regulations, standards, and procedures and eliminate unreasonable risk to health and the environment.
* Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.
* Report all safety and/or environmental incidents to management immediately.
* Other duties as assigned with or without accommodation
YOUR BACKGROUND
* BS/BA degree in Science/Business preferred
* Bachelor's degree in life sciences preferred
* Minimum 6 years experience in a pharmaceutical QA/Mfg environment
* ASQ inspection certification.
* Previous experience with statistical sampling plans.
* Previous experience in investigation root cause analysis and/or writing.
* Ability to work in a fast paced environment.
* Ability to adjust work schedule to meet operations and customer demand.
* Must be able to wear appropriate personal protective to insure safe execution of job responsibilities.
Cognitive Requirements:
* Skilled competency with computers, MS Office software required.
* Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred
WHY JOIN US
We offer continued personal development. When you join Guerbet, you:
* Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
* Are joining our 3000 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
* Are joining a company where we value diversity of talents coming from various horizons.
Do you want to help improve patients' lives with us?
We look forward to meeting you and continuing our story together!
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is a signatory of the Diversity Charter.
We believe diversity is a source of strength, and all our positions are open to everyone.
Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.
Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company's personnel representative if you need assistance completing this application or to otherwise participate in the application process.
Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
Intern - Process Engineering (May-December 2026)
Process engineer job in Cary, NC
Veolia is a global leader in environmental services, operating across all five continents with nearly 218,000 employees. Specializing in water, energy, and waste management, Veolia designs and implements innovative solutions for decarbonization, depollution, and resource regeneration, supporting communities and industries in their ecological transformation. Within this framework, Water Tech brings together a dedicated team of experienced professionals committed to tackling the world's most complex challenges related to water scarcity, quality, productivity, and energy. Together, we pursue a shared mission to create a more sustainable future.
Job Description
Position Summary:
The purpose of this position is to provide assistance for our Process Engineering department which provide engineering support for our water and wastewater treatment projects. This position will take place from May-December 2026.
ESSENTIAL DUTIES AND RESPONSIBILITIES
With each term and experience gained, it is expected that this position will take on more complex projects and responsibilities. This position will support the following general activities with close guidance from management and/or senior level group members.
● Provide support to the Process Engineering Department with a focus on:
Standardization and updating of Process Documentation, plant data, and templates
Development and maintenance of technical training slides
Gain ability to assist with development of project specific designs and budget proposals
Gain ability to assist with review of project specific contract documentation to ensure equipment compliance
Experience gained in this position will include knowledge of the equipment provided, process design tools utilized, safety standards applied, and other requirements needed to support projects in the water and wastewater treatment industry.
Qualifications
Qualifications
EDUCATION AND EXPERIENCE
● Currently working towards a Bachelor's Degree in engineering; Chemical or Environmental Engineering preferred.
● Coursework related to process design of water and wastewater treatment is a plus.
● Interest in a career in water and wastewater treatment is a must.
● Knowledge of Google Suites is a plus.
Additional Information
At Veolia, we realize diverse teams make smarter decisions, deliver better results, and build stronger
communities. We're an organization that champions diversity and inclusion at every rung of the ladder
and are proud to be an equal opportunity workplace. Because our people are our greatest assets, we
also offer competitive compensation and benefits that include:
Medical, Dental, & Vision Insurance Starting Day 1!
Life Insurance
Paid Time Off
Paid Holidays
Parental Leave
401(k) Plan - 3% default contribution plus matching!
Flexible Spending & Health Saving Accounts
AD&D Insurance
Disability Insurance
Tuition Reimbursement
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this
posting. The Company reserves the right to modify this information at any time, subject to applicable
law.
****Applicants are required to be eligible to lawfully work in the U.S. immediately; employer will not
sponsor applicants for U.S. work authorization (e.g. H-1B visa) for this opportunity****
Veolia does not accept unsolicited resumes from external recruiting firms. All vendors must have a
current and fully executed MSA on file before submitting candidates. Any unsolicited resumes and
candidate profiles will be deemed the property of Veolia, and no fee will be due.
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
Principle Process Engineer
Process engineer job in Durham, NC
Insight Global is seeking a Principle Process Engineer to work at one of our largest pharmaceutical manufacturing companies in Durham, NC. The Principal Process Engineer will own manufacturing process equipment and ensure site infrastructure supports cGMP operations. This role focuses on equipment design, implementation, troubleshooting, and continuous improvement for upstream and downstream bioprocessing systems, with a strong emphasis on single-use technologies.
Key Responsibilities
Serve as system owner for upstream and downstream process equipment, including single-use bioreactors (up to 2000L), filtration systems, and chromatography skids.
Define equipment requirements, specifications, and standards for facility fit; support installation, commissioning, qualification, and validation.
Lead equipment-focused projects: upgrades, new installations, and process improvements; develop business cases and manage timelines and budgets.
Collaborate with MS&T, Manufacturing, Quality, and Engineering teams to troubleshoot equipment issues and ensure GMP compliance.
Author and maintain SOPs, engineering studies, and process documentation; support CAPA, change control, deviation investigations, and risk assessments.
Evaluate and implement new technologies (e.g., single-use systems, PAT tools) to enhance scalability and efficiency.
Support capital projects, including facility design and equipment selection.
Represent process engineering in audits and regulatory filings.
Technical Focus
Upstream: Mammalian cell culture, seed expansion, harvest, filtration; single-use bioreactors (2000L scale).
Downstream: Chromatography (capture/exchange columns), single-use skids, filtration systems.
Familiarity with Unicorn (method development), Wonderware, and Allen Bradley FactoryTalk for process control.
Experience with P&IDs, cleaning validation, and GMP documentation.
Requirements
Bachelor's or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
10+ years in bioprocess engineering within biotech or biopharmaceutical manufacturing.
Expertise in upstream and downstream processes, single-use technologies, and GMP compliance.
Strong troubleshooting, project management, and cross-functional collaboration skills.
Process Development Associate (Attribute Sciences)
Process engineer job in Holly Springs, NC
Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Associate (Attribute Sciences)
What you will do
Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.
In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
Execute methods, author reports and ensure safety and compliance for all activities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
Associate's degree and 2 years of Process Development / Chemistry or related experience OR
Bachelor's degree
Preferred Qualifications:
Degree in Chemistry or related area.
Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR).
Experience in method transfers, method validation, and method troubleshooting.
Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
Effective oral and verbal communication skills.
Technical writing skills and attention to details in documents.
A self-starter and valuable teammate.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
79,971.00 USD - 89,221.00 USD
Auto-ApplySemiconductor Process & Device Failure Analysis Intern
Process engineer job in Durham, NC
MACOM designs and manufactures semiconductor products for Data Center, Telecommunication and Industrial and Defense applications. Headquartered in Lowell, Massachusetts, MACOM has design centers and sales offices throughout North America, Europe and Asia. MACOM is certified to the ISO9001 international quality standard and ISO14001 environmental management standard.
MACOM has more than 75 years of application expertise with multiple design centers, Si, GaAs and InP fabrication, manufacturing, assembly and test, and operational facilities throughout North America, Europe, and Asia. View our facilities at ********************** In addition, MACOM offers foundry services that represents a key core competency within our business.
MACOM sells and distributes products globally via a sales channel comprised of a direct field sales force, authorized sales representatives and leading industry distributors. Our sales team is trained across all of our products to give our customers insights into our entire portfolio.
Semiconductor Process & Device Failure Analysis Intern
Role Overview:
As a member of the Technology Development team, the Semiconductor Process & Device Failure Analysis Intern will work alongside experienced engineers providing mentoring, guidance, and introductions to colleagues.
This Internship with MACOM will help the Intern to gain valuable work experience in a key discipline, build professional relationships, and take ownership of a business-critical project.
During the 12 weeks each Intern will:
> Be given an individual and well-defined project with set outcome goals
> Gain hands on experience
> Receive excellent training and ongoing supervision
> Be invited to attend an intern webinar series
> Attend networking/social events
> Attend and present at Poster Session about each Interns project successes and pitfalls
> Receive formal, written feedback
Requirements:
* Currently enrolled in a Master's or Doctoral degree in MSE, ECE or similar engineering degree program.
* Prerequisite Skills and Experience:
* Familiarity with electronic device fabrication processing technology and device mask layout principles are preferred.
* Familiarity with epitaxial growth of GaN high electron mobility transistor (HEMT) on SiC and Silicon substrates.
* Prior experience with electrical probe testing/curve tracing and high resolution optical microscopy.
* Understand the capabilities of acoustic microscopy, focused ion beam (FIB) cross sectioning, secondary electron microscopy (SEM) inspection, scanning transmission electron microscopy (STEM) analysis and have versatility in the Microsoft Office Suite and statistical analysis software such as JMP.
* Direct experience in one or more of these characterization techniques is preferred.
* Excellent oral and written communication skills and will be expected to present data and findings both verbally and in written reports.
Additional Desirable Skills:
* Familiarity with principles and characterization of radio frequency transistor devices.
* Familiarity with mask layout principles and the ability to view .gds files in a layout editor.
* Familiarity with epitaxial wafer characterization methods (e.g., sheet resistance mapping, photoluminescence mapping, etc.)
EEO:
MACOM is an Equal Opportunity Employer committed to a diverse workforce. MACOM will not discriminate against any worker or job applicant on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, genetic information, veteran status, military service, marital status, or any other category protected under applicable law.
Reasonable Accommodation:
MACOM is committed to working with and providing reasonable accommodations to qualified individuals with physical and mental disabilities. If you have a disability and are in need of a reasonable accommodation with respect to any part of the application process please call *************** or email