Title: Manufacturing Technology Project Engineer
The Manufacturing Technology Project Engineer is responsible for improving manufacturing processes by evaluating and implementing advanced engineering technologies, equipment and tooling. Oversee the procurement and implementation of manufacturing technologies within Deringer-Ney, Inc. to improve quality, efficiency and cost.
Supervisory Responsibilities:
None.
Duties/Responsibilities:
Identify and evaluate potential equipment and tooling suppliers, manage the sourcing process to secure high-quality equipment and tools at optimal cost and delivery terms.
Prepare return of investment analysis to justify investment in selected technology, equipment and tooling.
Work closely with internal teams (design, process and quality engineers, maintenance, etc.) to facilitate and manage overall project implementation through IQ/OQ/PQ process
Foster strong relationships with vendors and oversee the design, development and fabrication of manufacturing equipment and tooling.
Ensure manufacturing solutions meet the required quality standards, certifications, regulatory requirements, customer specifications, production timelines and budget.
Support the Design Engineers by suggesting ideas to make the detail components or assemblies more cost effective and producible
Required Skills/Abilities:
Strong understanding of manufacturing processes (e.g. wire draw, strip rolling, stamping , machining, plastic injection molding).
Knowledge of quality control standards and regulatory compliance, especially in medical and automotive sectors.
Excellent communication, problem-solving, and project management skills.
Ability to work collaboratively in a cross-functional team environment.
Education and Experience:
Bachelor's degree in materials science (metallurgy), mechanical engineering or Industrial Engineering.
Minimum 5 years of manufacturing experience in production environment.
Experience as a Metallurgy Manufacturing Engineer is strongly preferred.
Physical Requirements:
Prolonged periods of sitting or standing.
Must be able to lift 15 pounds at times.
Must be able to access and navigate each department at the organization's facilities.
$78k-101k yearly est. 3d ago
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Principal Engineer, AI-Driven QC & Data Consumption
Vertex Pharmaceuticals (San Diego) LLC 4.6
Boston, MA jobs
A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package.
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$105k-132k yearly est. 3d ago
Test Manufacturing Engineer Technician - Peoria, Illinois
Industrial Technology Co 3.7
Peoria, IL jobs
Provide support to the Test Manufacturing Engineers, with daily production tasks, within the LPSD transmission assembly facility. The job responsibilities may include working with product engineering groups, test equipment vendors and manufacturing associates that enable test processes consistent with lean manufacturing principles for transmission and torque converter products. The test engineer technician will strive to continuously assist with reducing test cycle times while maintaining the quality and integrity of existing test processes. The test engineer technician bulk of workload will be to develop and improve standard work, safety risk assessments, and work element sheets for the test stands. Suitable candidates would possess at least 2 years of relevant engineering experience in the areas of test / development, product design or transmission / engine controls.
REQUIREMENTS:
* Minimum Bachelor's degree in mechanical, electrical, or manufacturing engineering.
* Previous experience in assembly or test operations environment.
* Knowledge of transmission function and hydraulic and electro-hydraulic controls systems.
* Data analysis and logical decision making.
* PC and mainframe system computer skills including Microsoft software applications
* Strong Interpersonal skills including teamwork, judgment, initiative, dedication, communication
* Strong organizational and planning skills.
* Familiar with 6 Sigma methalogy
Candidates must be authorized to work in the United States.
This employer is not currently hiring foreign national applicants that require or will require sponsorship tied to a specific employer.
$47k-63k yearly est. 11d ago
Engineer, Process - Belvidere, NJ
DSM 4.3
Belvidere, NJ jobs
Engineer, Process Onsite As a ProcessEngineer, you will be responsible for providing technical direction for a defined portion of the production process; improve product performance; manage and improve daily process performance; and introduce new product forms to a spray dry vitamin manufacturing line.
You will share responsibility for the department's performance in the areas of safety, health, environment, quality, and production; provide technical support for other areas as needed and generally, work independently with direction and priorities based on needs of the process.
At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.
Key Responsibilities:
* Observes, analyzes and interprets information from process operations to identify areas for optimization. Assists Technicians with establishing and maintaining predictive/preventative programs for the area. Analyzes and solves, or manages the resources to address, technical/operational problems related to the assigned process. Leads and facilitates process troubleshooting. Provides engineering expertise to the department and may serve as an expert to the organization.
* Conceives, plans, develops, and recommends proposals for optimizing production capacity/capability in assigned process. Establish new and improve current process operating parameters. May manage small capital projects for area and is a resource on large projects.
* Maintains a presence in production areas, an awareness of process performance and accessibility to all process team members. Responsive and timely in addressing team member requests.
* Leads focus improvement projects and efforts (employee idea generation, root cause analysis). Provides coaching and training to operations personnel as needed.
* SHE Duties & responsibilities: Displays and always promotes positive safety behaviors. Understands and implements SHE critical equipment/parameters/material specifications. Follows the management of change (MOC) process and ensures that change control documentation (e.g. P&ID CAD drawings, red lines, PSM, SOPS, ISO etc.) is completed for process changes. Participates in and leads investigations of safety/environmental incidents including root cause analysis and the development and execution of corrective actions. Utilizes company systems for action tracking and reporting. Participates in and leads HAZOP/pre-startup safety reviews. All employees are to be aware of and follow all DSM Life Saving Rules. Ensure that SHE related training is current and up to date.
* Quality duties & responsibilities: Writes protocols and SOPs for implementation of new products and manufacturing processes. Understands and follow validation work processes. Participates in and leads quality investigations related to deviations and failures. May review and sign batch records and reports non-conformances. Adjust and calculate formulations for batch records as needed.
* Other duties assigned by Belvidere leadership.
We Bring:
* Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
* A chance to impact millions of consumers every day - sustainability embedded in all we do
* A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next
* Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership
* A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on.
* A community where your voice matters - it is essential to serve our customers well.
You Bring:
* BS in Engineering (or relevant technical discipline) required; Chemical Engineering preferred.
* Knowledge and understanding of SAP, quality systems (cGMPs, ICHQ7A, ISO), environmental, regulatory and safety compliance.
* Knowledge of Lean and six sigma manufacturing practices
* Detailed knowledge of relevant Safety, Health, and Environmental practices such as PHA, RCA, etc.-
* A minimum of 1-2 years' relevant experience required, preferably in the chemical/pharmaceutical industry
* Must be available to support shift, weekend and holiday schedules as required.
* Must be able to perform the essential functions of the job, including but not limited to field inspection and evaluation of process equipment, systems and facilities.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary Range: $64,300 - $118,700.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, Belonging and Equal Opportunity Statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency Statement
Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency's fees, percentages or similar.
$64.3k-118.7k yearly 54d ago
Process Engineer, Fermentation - Belvidere, NJ
DSM 4.3
Belvidere, NJ jobs
Engineer, Process (Fermentation)
Onsite
As an Engineer, Process in Fermentation, you will provide technical direction for a defined portion of the production process and share responsibility for departmental performance in safety, health, environment, quality, and production. Working independently, you will prioritize tasks based on process needs. You will collaborate closely with the production team-including the Production Manager, ProcessEngineers, Technical Coordinator, and Operators-and represent Production on project work, partnering with Senior Engineers, Maintenance, and the Director of Operations. At times, you may supervise project teams. As the ARA process owner, you will ensure volumes and quality meet business requirements.
At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.
Key Responsibilities:
Observes, analyzes and interprets information from process operations to identify areas for optimization. Assists Technicians with establishing and maintaining predictive/preventative programs for the area. Analyzes and solves, or manages the resources to address, technical/operational problems related to the assigned process. Leads and facilitates process troubleshooting.
Conceives, plans, develops, and recommends proposals for optimizing production capacity/capability in assigned process. May manage small capital projects for area and is a resource on large projects.
Assists in setting, tracking and meeting department goals. Supports plant and corporate initiatives as outlined in the manufacturing plan. Promotes teamwork and cooperation.
Adheres to equipment/material specifications. Follows the change control process and ensures that change control documentation (e.g. P&ID CAD drawings, red lines, PSM, SOPS, ISO etc.) is completed for process changes.
Reviews and signs batch records and reports non-conformances. Participates in and leads investigations into non-conformances and completes investigation documentation.
Implements SHEQ policy compliance within work group. Participates in and leads investigations of safety/environmental incidents including root cause analysis and the development and execution of corrective actions. Participates in and leads HAZOP/pre-startup safety reviews. Responsible for insuring regulatory compliance for process critical control points (e.g., vent control devices) as assigned.
Other duties assigned by Belvidere leadership.
We Bring:
Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
A chance to impact millions of consumers every day - sustainability embedded in all we do
A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next
Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership
A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on.
A community where your voice matters - it is essential to serve our customers well.
You Bring:
BS in Chemical Engineering (or rel. technical discipline) required.
1-2 years relevant experience required, preferably in the chemical industry.
Knowledge and understanding of personal computers, SAP, quality systems (cGMPs, ICHQ7A, ISO), environmental, regulatory and safety compliance.
Knowledge of relevant Manufacturing Excellence work processes such as Asset Utilization and Operate Plant Normal.
Knowledge of relevant Safety, Health, and Environmental practices such as PHA, RCA, etc.
Must have good communications skills and the ability to present ideas effectively. Demonstrates ability to manage multiple projects and work in a team environment.
Where necessary, should be knowledgeable in the operation of process control instruments and systems.
Must be available to support shift, weekend and holiday schedules as required.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary Range: $64,300 - $118,700.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, Belonging and Equal Opportunity Statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency Statement
Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency's fees, percentages or similar.
$64.3k-118.7k yearly 52d ago
Process Engineer
Aerogen 4.4
Foster City, CA jobs
Pharma
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.
We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.
Join us as we embark on this breakthrough and become inspired to deliver.
What is the role?
The person in this role will conduct process experiments to support the development of commercially viable lipid-peptide and lipid-protein formulations. In addition, the person will support analytical efforts as needed and be trained on various lab instrumentation.
This role is crucial for advancing our CMC program for the Gates project, as well as establishing analytical capabilities and in-house expertise in our expanding portfolio, ensuring products meet rigorous quality and regulatory standards. The person will be hands on in the lab with strong technical knowledge in chemical engineering and will be mentored to assisting analytical development efforts.
What are the key responsibilities?
Chemical engineering: Develop and optimization formulation unit-operations methods and support design of experiment studies.
Analytical science: Support development efforts by participating in analytical experiments and using specialized equipment, with guidance from analytical staff.
Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs).
Cross-Functional Collaboration: Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals.
Troubleshooting & Problem Solving: Address and resolve complex process issues during development and manufacturing.
Continuous Improvement: Stay updated on advancements in manufacturing and industry trends.
What Education and Experience are required?
A degree in Chemical engineering, Biochemical engineering or related field.
2-5 years of manufacturing process development experience.
Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus.
Experience in technical writing is required.
Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus.
Knowledge and experience in drug-device development, inhalation drug delivery is a plus.
Excellent written and oral communication skills.
What key skills will make you great at the role?
Technical expertise: Proficiency in process development and engineering of formulations. Experience with drug combination products is a plus. Understanding of laboratory procedures, equipment, software, and data analysis.
Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance.
Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's objectives.
Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment.
Compliance and safety: Ensure a safe and complaint work environment.
Training, procedures, quality: Ensure up to date training on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements.
Why Aerogen Pharma?
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
$86k-116k yearly est. 46d ago
Soft Gel Process Engineer (54073)
Best Formulations 4.4
Industry, CA jobs
Founded in 1984, Best Formulations LLC, a diversified nutraceutical and personal care company headquartered in City of Industry, California, is a contract manufacturer of thousands of branded SKUs, including high quality nutritional supplements including softgels, tablets, capsules, powders, teas, dietary supplements, and vegetarian softgels.
About the role:
We are a trusted partner to our customers when it comes to innovation and have one of the strongest R&D, product formulation and technical teams in the industry. We are recognized as the leader in plant-based softgel innovation and our ability to encapsulate difficult formulas. We seek out innovation across our entire business and pass that knowledge and expertise to our customers.
As a ProcessEngineer, you will be responsible for all aspects of product scale-up and commercialization activities, and supports operations by identifying and implementing process improvements to improve product quality, reduce operating costs, and increase production capacity. As an integral part of continuous improvement efforts, provides leadership, guidance and training to improve efficiencies in operations. Explores relevant enabling technologies, with focus on driving cost savings. Provides functional technical support to R&D, Quality and other functional areas.
How will you contribute:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. Essential job functions and duties include, but are not limited to:
Conducts process-monitoring activities, and performs machinery capability studies.
Creates, updates, and enforces SOPs and JIs, as required.
Trains operators, leads, supervisors and other personnel on new equipment, JIs, and SOPs,
Conducts & leads production trouble-shooting, identifies and implements viable solutions.
Identifies and delivers advancements in continuous product/process improvements.
Continuously explores, identifies and develop innovative proprietary solutions and cost savings.
Lead or assist in CAPA or DOE activities.
Review formulations, MBR, Batch records, protocols, change controls and other process instructions to confirm capability and capacity.
Generate Process Qualifications Protocols (PQs) and perform Process Qualifications.
Work closely with R&D and Engineering on equipment selection process.
Perform Installation Qualifications (IQ) and Operational Qualifications (OQ) activities.
Maintains accurate records of all projects and assignments.
Complies with all Company policies and procedures, including safety rules and regulations.
Maintains a safe work environment and operates in a safe manner.
Perform other job duties related to the job, as assigned by management.
Qualifications
Minimum Requirements/Qualifications:
Bachelor Degree in Chemical/Mechanical Engineering or related field from an accredited college/university
One to Three (1-3) years of work experience in an industrial setting
Project management experience is a strong plus.
Work Environment:
May involve exposure to allergens such as Soy, Wheat, Fish, Shellfish, Milk, Egg, Tree Nuts and Sesame.
What Best Formulations can offer you:
401(k) with company match
Tuition reimbursement
Medical/Dental/Vision/Pet Insurance
Health & Wellness programs
Generous time off for vacations
More about us:
As a valued strategic partner, Best Formulations offers a comprehensive program of services, turnkey solutions, and client support that is unmatched in the industry. Our product development team can provide customized, proprietary formulations designed specifically to meet the needs of our customers and their method of distribution. Our vertically integrated manufacturing and packaging process allows us to schedule flexible production runs to respond quickly to shifting market demands. Every step of the way, we are committed to your growth and success!
"To develop and strengthen mutually beneficial relationships with our employees, customers, and business partners by providing the highest quality products and the Best customer service. Together We Grow!"
This position is currently classified as on-site.
Base Salary Range: $90,000.00 - $110,000.00 per year, based on candidate professional experience level. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Holidays, Vacation, Tuition Reimbursement Program.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee's employment term, at the sole discretion of management.
EEO Statement
Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.
**Please no external recruiters**
$90k-110k yearly 21d ago
Manufacturing Sciences & Technology (MSAT) Process Engineer, 2nd/3rd Shifts
Orca Bio 4.1
Sacramento, CA jobs
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
Summary of Role: The MSAT ProcessEngineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
2nd shift: working on-site Monday through Friday, from 3pm to 11:30pm.3rd shift: working on-site Monday through Thursday, from 9pm to 7:30am.Physical Demands
Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Responsibilities
Performs ongoing monitoring of existing commercial products and processes
Generate metrics and reports for process monitoring and continuous process verification
Support process improvements and changes including electronic batch record creation and modifications
Investigates process events and implements corrective and preventive actions
Provides troubleshooting support for manufacturing events, equipment performance and material issues
Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities
Education & Experience Requirements
B.S. in Engineering or similar fields
3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
Prior experience in regulated, GMP manufacturing operations
Experience in biotechnology and cell therapy manufacturing preferred
Strong communication and problem solving skills, with a desire to improve upon established processes
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
To learn more: **********************************
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
$86k-115k yearly est. Auto-Apply 3d ago
Process Engineer
Sun Pharmaceuticals, Inc. 4.6
Princeton, NJ jobs
This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost effective solutions for manufacturing. 1. Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures.
2. Produce APIs and intermediates according to preapproved instructions;
3. Review all production batch records and ensure that these are completed and signed.
4. Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded).
5. Ensure that production facilities are clean and disinfected;
6. Ensure that all necessary calibrations are performed (with records kept)
7. Maintain the premises and equipment (with records kept).
8. Ensure that validation protocols and reports are reviewed and approved;
9. Evaluate proposed changes in product, process or equipment.
10. Responsible for ensuring that new and modified facilities and equipment are qualified.
11. Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes.
12. Manage assigned projects in order to complete each project on time, under budget and within the design parameters.
13. Provide training for API processes.
14. Other duties as assigned.
**Education, Experience & Competencies**
1. BS in Chemical Engineering.
2. 5 years experience with FDA/GMP. Experience with DEA guidelines and regulations a plus.
3. Excellent organization skills.
4. Ability to present ideas effectively to all levels of management.
The presently-anticipated base compensation pay range for this position is $101,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.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.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
$101k-112.5k yearly 45d ago
Manufacturing Engineering Technician II (3 Month Contract)
Tandem Diabetes Care 4.6
California jobs
GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.
STAY AWESOME:
Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com
A DAY IN THE LIFE:
Performs functions associated with all manufacturing operations. Works with engineers in set-up and development of support processes. Assists in the development and execution of protocols and test runs. Design, implement and maintain production support processes. Assess manufacturing processes for compliance with written policies and procedures including QSR's and cGMP practices. Assembles and initiates documentation change order packages. Proactively communicates notifications on problems and issues.
Manufacturing Engineering Technician II's at Tandem are also responsible for:
Maintains, operates and develops processes in support of manufacturing operations.
Performs assessments of procedures within the manufacturing environment, identifying non-conformances, recommending and implementing corrective and preventative actions.
Performs all manufacturing assignments in accordance with established safety procedures and applicable regulatory requirements.
Contributes to and develops equipment operating procedures (EOPs) and preventative maintenance (PMs) plans as requested.
Develops and releases written and picture-based work instructions.
Participates in continual process improvement activities designed to optimize quality, compliance, process efficiency, and lead times.
Executes process validation and qualification protocols and documents results and findings as required.
Provides training, as required, to production personnel on procedure, and process changes.
Assists in the implementation Lean Manufacturing and 6 sigma techniques.
Other duties as assigned.
WHEN & WHERE YOU'LL WORK:
Onsite: This position is fully onsite and open to candidates located in San Diego, California. Equipment for the role will be provided and training will occur onsite.
Schedule: This position will work Monday - Thursday from 2:30 PM - 1:45 AM PST.
WHAT YOU'LL NEED:
1. Knowledge, skills & abilities:
Knowledgeable with QSRs.
Must have strong cGMP documentation skills.
Working knowledge of small scale electromechanical device assembly operation,
Ability to effectively share information regarding issues in written or verbal form and making recommendations in a clear and concise manner.
Skilled at promoting team cooperation and a commitment to team success.
Demonstrated ability to effectively prioritize and handle multiple priorities and complete assignments on time and with minimal errors.
Proficient with Microsoft Office and Internet.
2. Minimum certifications/educational level:
Associate degree in a technical discipline, or applicable job experience and education.
3. Minimum experience:
4+ years of experience in Instrumentation or Biomedical Industries, or Consumer Electronics.
Experience in FDA/GMP/ISO environment.
Lean Manufacturing experience desirable.
COMPENSATION:
The starting base pay range for this position is $25.19 to $31.47 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market.
Please note that is a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based upon business need and job performance.
YOU SHOULD KNOW:
Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.
Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.
SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
WHY YOU'LL LOVE WORKING HERE:
At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at ***************************************
BE YOU, WITH US!
We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.
Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.
REFERRALS:
We love a good referral! If you know someone who would be a great fit for this position, please share!
APPLICATION DEADLINE:
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.
#LI-HJ1
$25.2-31.5 hourly Auto-Apply 24d ago
Process Engineer - Princeton, NJ
DSM 4.3
Princeton, NJ jobs
ProcessEngineer Princeton, NJ The ProcessEngineer will work closely with cross-functional teams to identify areas for improvement and implement solutions to optimize production processes and reduce losses. The ProcessEngineer is expected to develop technical understanding and mastery of critical process points, manufacturing processes, raw materials and their functions, interactions between formula components and maturation, maceration, mixing processes. This includes conducting root cause analysis, developing, and implementing corrective and preventative actions. It will also be responsible for capturing, analysing and interpreting data from the production areas (Non-Conformances, performance results such as OEE (Over Effective Effectiveness), shutdowns, automation rate, etc.)
Your key responsibilities
* Being the primary point of contact with the site's continuous improvement team for your area
* Taking ownership of the process control system, ensuring its proper functioning and identifying opportunities for improvement
* Participating in daily operational meetings and utilizing data-driven insights to eliminate losses, particularly in the areas of quality (non-conformities), production reliability, and continuous improvement projects
* Developing and executing plans to eliminate losses and address capacity/productivity gaps, leveraging the site's continuous improvement plan as a guide
* Compiling and interpreting data from your areas to prioritize loss elimination opportunities, utilizing advanced tools such as Loss Tree and Loss Allocation to create both current and future state loss trees
* Providing support for the implementation of new products and projects, leveraging your technical expertise and knowledge to ensure successful outcomes
We bring
* Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
* A chance to impact millions of consumers every day - sustainability embedded in all we do
* A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next
* Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership
* A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on.
* A community where your voice matters - it is essential to serve our customers well.
You bring
* Degree in Engineering preferably: Chemical, Mechanical, Manufacturing, Food, Electrical, Control and Automation, Industrial, etc.
* 4-6 years of professional experience in processengineering, preferably in a manufacturing environment.
* Proficiency in SAP is a plus
* Strong data analysis skills, including proficiency in Excel and visualization tools. We are looking for someone who can effectively interpret and communicate complex data insights to drive decision-making
* A background in continuous improvement, with experience in Lean Six Sigma methodologies is a strong plus. We value a data-driven approach to problem-solving
* Knowledge of TPM (Total Production Maintenance) & other continuous improvement methodologies
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $94,600 - $105,000.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
$94.6k-105k yearly 44d ago
Manufacturing Process Engineer
The Panther Group 3.9
Manchester, CT jobs
Our client, a well-established precision manufacturing organization is looking for a Manufacturing ProcessEngineer to support the development and optimization of production processes for both new and existing products. Key Responsibilities
Develop, assess, and refine manufacturing methods to support new product introductions and ongoing production
Translate customer requirements and technical documentation into efficient, repeatable manufacturing processes
Investigate and resolve production challenges related to machining, tooling, and equipment performance
Design and improve fixtures, tooling, and process layouts to enhance quality and throughput
Create and maintain detailed process documentation, including operation sheets and engineering drawings
Collaborate cross-functionally with internal teams, suppliers, and customers to support production needs
Review and implement engineering changes and manufacturing documentation updates
Analyze production data and technical specifications to evaluate manufacturability and process capability
Apply continuous improvement principles to reduce waste, improve efficiency, and increase capacity (e.g., root cause analysis, setup reduction, standard work, error-proofing)
Qualifications
Bachelor's degree in Engineering or a related technical discipline (materials, metallurgy, or similar preferred)
5+ years of experience in a manufacturing engineering role within a regulated or high-precision environment (aerospace experience strongly preferred)
Familiarity with quality management systems such as ISO 9001 and/or AS9100
Proficiency with CAD/CAM tools (e.g., SolidWorks, Mastercam) and ERP/MRP systems
Strong analytical and problem-solving skills with the ability to collaborate effectively in a team setting
Practical machining knowledge or hands-on manufacturing background
$67k-90k yearly est. 17d ago
Project Process Engineer
Hikma Pharmaceuticals USA Inc. 4.9
Cherry Hill, NJ jobs
Job Title: Project ProcessEngineer
Job Type: Full-time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project ProcessEngineer. In this role, you will be responsible for overseeing all project aspects from conception to completion. Activities such as scope development, budgeting, design, procurement, scheduling, construction management, installation, and commissioning will be under your direction. In addition, as you become familiar with the site, you will provide technical expertise to troubleshoot and optimize systems and equipment. In this role, you will focus on projects and engineering support relating to site utilities/infrastructure, facilities, and HVAC.
Key Responsibilities:
Building systems and utilities such as site electrical infrastructure, compressed air, plant steam, chilled water, and condenser/tower water.
Critical utilities such as WFI, clean steam, and oil free process air.
Cleanroom HVAC equipment and BMS/BAS control, monitoring, and alarming systems.
A wide variety of facilities projects such as cleanroom construction, facility upgrades, cold storage chambers, stability chambers, warehouse upgrades, office area renovations, etc.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
Minimum: B.S. Degree in Engineering and five (5) years of project engineering or maintenance engineering experience.
Strong organizational skills and engineering knowledge.
Excellent communication and time management abilities.
Demonstrated ability to apply project management tools and techniques to engineering projects in multiple disciplines.
Technical investigation and troubleshooting skills especially related to HVAC issues.
Decision making ability and leadership skills.
Working knowledge of cGMPs as they relate to sterile pharmaceutical manufacturing.
Demonstrated knowledge of pharmaceutical manufacturing facilities, critical utilities, and production equipment with respect to their design, installation, and operation.
Strong proficiency with Microsoft Office.
Basic AutoCAD skills.
Experience with Siemens Apogee or Desigo is a plus.
Professional Engineering license or PMP Certification is a plus.
Preferred Qualifications:
Preferred: B.S. Degree in Mechanical Engineering and five to fifteen years of project engineering or maintenance engineering experience in the pharmaceutical industry.
Professional Engineering License with HVAC emphasis.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
$71k-93k yearly est. 60d+ ago
Process Engineer - Plasma Spray & HVOF
Propulsion Technologies 3.5
Hollywood, FL jobs
Job Description
Role Summary/Purpose:
The ProcessEngineer - Plasma Spray & HVOF will provide specialized expertise in thermal spray coating processes, focusing on Plasma Spray and High-Velocity Oxygen Fuel (HVOF) applications. This role is integral to supporting aerospace manufacturing operations, ensuring adherence to OEM standards, and driving continuous improvement initiatives. The engineer will collaborate closely with cross-functional teams to optimize coating processes, enhance product quality, and maintain compliance with industry regulations.
Essential Responsibilities:
Lead the development, implementation, and optimization of Plasma Spray and HVOF coating processes to meet product specifications and quality standards.
Provide technical support to manufacturing teams, addressing process-related issues and implementing corrective actions as necessary.
Create and maintain detailed work instructions, process flows, and technical documentation in compliance with aerospace industry standards.
Ensure all processes align with OEM specifications and regulatory requirements.
Conduct thorough root cause analysis for process deviations, quality issues, and failures.
Develop and implement corrective and preventive actions to mitigate recurrence.
Apply lean manufacturing principles to streamline processes, reduce waste, and improve efficiency.
Lead or participate in continuous improvement initiatives, utilizing tools such as Six Sigma, 5S, and Kaizen.
Provide training and mentorship to team members on Plasma Spray and HVOF processes, equipment, and safety protocols.
Foster a culture of knowledge sharing and collaboration within the team.
Work closely with cross-functional teams, including design, quality, and production, to ensure seamless integration of coating processes into manufacturing workflows.
Communicate effectively with stakeholders to report on process performance, improvements, and challenges.
Qualifications:
Bachelor's degree in Chemical, Materials, Mechanical Engineering, or a related field or certification
3-5 years of hands-on experience with Plasma Spray and HVOF coating processes, preferably in aerospace manufacturing.
Equivalent combinations of relevant education and work experience will also be considered in lieu of stated requirements
Experience in creating and managing technical documentation and work instructions.
Strong understanding of thermal spray coating technologies, materials science, and surface preparation techniques.
Proficiency in CAD software (e.g., SolidWorks) for process design and simulation.
Familiarity with aerospace industry standards, OEM specifications, and regulatory requirements.
Experience in Maintenance, Repair, and Overhaul (MRO) environments is desirable.
Demonstrated ability to perform root cause analysis and implement effective corrective actions.
Strong analytical skills with attention to detail.
Knowledge of lean manufacturing principles and experience in applying them to improve process efficiency.
Ability to work collaboratively in a team environment, sharing knowledge and supporting team objectives.
Physical Demands / Work Environment:
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Frequently required to sit, stand, regularly use full range of motion of upper and lower extremities, regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Exposure to chemicals, noise, varying temperatures, and other workplace hazards however, PTI has established process, procedures, and protective equipment to reduce or eliminate exposures to these hazards and full compliance is a requirement of the job.
About Us
Propulsion Technologies International, LLC (PTI), a joint venture between GE Aviation & Safran Aircraft Engines, offers a great work environment with fast-paced, challenging and rewarding careers. Both GE & Safran are world leaders in the design and manufacture of aircraft engines, propulsion systems, & aircraft equipment. This could be your opportunity to join the exciting aviation industry!
We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
PTI will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen.
$65k-88k yearly est. 16d ago
Associate, Process Development
Charles River Laboratories 4.3
Memphis, TN jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
The Process Development Associate I position involves collaborating with senior roles, such as scientists and senior scientists, to assist in planning and conducting experiments. This includes preparatory tasks, equipment setup, and hands-on involvement during experiments.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Participates in research and development activities. May perform some procedures independently without direct supervision.
* Assist other personnel in set up and planning of experiments. This includes the set-up of necessary equipment, and preparation of buffers and/or reagents.
* Assist senior personnel in performing experiments.
* Utilizes established mathematical and scientific techniques to compile and analyze data.
* Actively record data and procedures to help write technical reports detailing protocols, outcomes, and observations.
* Perform all other related duties as assigned.
**Job Qualifications**
QUALIFICATIONS:
* Bachelor's degree required.
* 0 - 1 year of experience in bioprocessing, biopharmaceutical, analytical and/or product development.
* Ability to contribute to moderately complex aspects of projects.
* Can work both independently and collaboratively.
The pay range for this position is $55,013 - $73,350. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Charles River's CDMO Services
With over 20 years of experience and industry-leading expertise, Charles River's cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities-including plasmid DNA, viral vector, and cell therapy manufacturing-enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
232019
$55k-73.4k yearly Easy Apply 2d ago
Process Engineer
The Panther Group 3.9
Riverview, FL jobs
ProcessEngineering is responsible for analyzing and assessing supplier and in-house processes to determine process capability. Identify and drive process improvements. Support supplier assessment and selection process. Employee will work with the implementation of new product development and process implementations. The documentation/qualification activities include but not limited to: feasibility studies, validation protocols, standard operating procedures changes, training material, drawings, raw material specifications updates etc. This resource will manage the site timeline for the project and will participate in the project management activities. This position will engage with suppliers and manage all external responsibilities.
Design and develop processes and equipment to improve productivity. Provide process control measures through validation plans, data analysis, and statistical process control techniques. Documentation and communication skills to manage projects, vendors, test plans, and present cost justifiable action plans and reports. Organizational skills to manage/prioritize task assignments, amongst unplanned troubleshooting tasks.
Maintain a clean and safe work environment for self and others. Display a sense of urgency, sound judgment, and pride in workmanship. Display self-motivation and the ability to work independently and as part of team. Utilize upward communication to keep supervisor informed of task status, job-related problems and other information related to work activity.
Essential Functions:
Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations.
Experience with change documentation package.
Statistical analysis and feasibility studies for new process
Ability to write clear and concise Test Protocols and Procedures
Good written and verbal skills
Self driven individual and result-oriented person
Experience with manufacturing environment and automated machines. Pharmaceutical experience is considered a plus.
Knowledge of modern computer programs to include project management software. Strong Computer skills & MS office suite (Excel, Word, Project etc.)
Ability to express ideas both in written and oral communications.
Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand.
Ability to deal with contractors in order to assist them with the equipment process commissioning.
Excellent interpersonal and reasoning skills.
Knowledge of design engineering tools such as AutoCAD, standard machine shop processes, and specialty shop capabilities.
Follow all certified standards, GMP, OSHA, plant policies and procedures
Sets the standard for timeliness, work ethic, and personal integrity
Positive attitude, result-oriented person.
Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes.
Qualifications:
Minimum 2 years of experience preferably in a medical manufacturing industry. Understanding of FDA regulations surrounding the manufacture of medical devices and GMPs.
Strong technical expertise on manufacturing equipment and process Project management experience Manufacturing equipment validation, Documentation updates
Preferred: Experience with printing systems and labeling management systems
Education required:
B.S. Mechanical or Electrical Engineering
Pay $30 - $41 / hour W2, depending on experience.
#INDENG
#ZR
$30-41 hourly 13d ago
Process Engineer - Plasma Spray & HVOF
Propulsion Technologies 3.5
Miramar, FL jobs
Role Summary/Purpose:
The ProcessEngineer - Plasma Spray & HVOF will provide specialized expertise in thermal spray coating processes, focusing on Plasma Spray and High-Velocity Oxygen Fuel (HVOF) applications. This role is integral to supporting aerospace manufacturing operations, ensuring adherence to OEM standards, and driving continuous improvement initiatives. The engineer will collaborate closely with cross-functional teams to optimize coating processes, enhance product quality, and maintain compliance with industry regulations.
Essential Responsibilities:
Lead the development, implementation, and optimization of Plasma Spray and HVOF coating processes to meet product specifications and quality standards.
Provide technical support to manufacturing teams, addressing process-related issues and implementing corrective actions as necessary.
Create and maintain detailed work instructions, process flows, and technical documentation in compliance with aerospace industry standards.
Ensure all processes align with OEM specifications and regulatory requirements.
Conduct thorough root cause analysis for process deviations, quality issues, and failures.
Develop and implement corrective and preventive actions to mitigate recurrence.
Apply lean manufacturing principles to streamline processes, reduce waste, and improve efficiency.
Lead or participate in continuous improvement initiatives, utilizing tools such as Six Sigma, 5S, and Kaizen.
Provide training and mentorship to team members on Plasma Spray and HVOF processes, equipment, and safety protocols.
Foster a culture of knowledge sharing and collaboration within the team.
Work closely with cross-functional teams, including design, quality, and production, to ensure seamless integration of coating processes into manufacturing workflows.
Communicate effectively with stakeholders to report on process performance, improvements, and challenges.
Qualifications:
Bachelor's degree in Chemical, Materials, Mechanical Engineering, or a related field or certification
3-5 years of hands-on experience with Plasma Spray and HVOF coating processes, preferably in aerospace manufacturing.
Equivalent combinations of relevant education and work experience will also be considered in lieu of stated requirements
Experience in creating and managing technical documentation and work instructions.
Strong understanding of thermal spray coating technologies, materials science, and surface preparation techniques.
Proficiency in CAD software (e.g., SolidWorks) for process design and simulation.
Familiarity with aerospace industry standards, OEM specifications, and regulatory requirements.
Experience in Maintenance, Repair, and Overhaul (MRO) environments is desirable.
Demonstrated ability to perform root cause analysis and implement effective corrective actions.
Strong analytical skills with attention to detail.
Knowledge of lean manufacturing principles and experience in applying them to improve process efficiency.
Ability to work collaboratively in a team environment, sharing knowledge and supporting team objectives.
Physical Demands / Work Environment:
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Frequently required to sit, stand, regularly use full range of motion of upper and lower extremities, regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Exposure to chemicals, noise, varying temperatures, and other workplace hazards however, PTI has established process, procedures, and protective equipment to reduce or eliminate exposures to these hazards and full compliance is a requirement of the job.
About Us
Propulsion Technologies International, LLC (PTI), a joint venture between GE Aviation & Safran Aircraft Engines, offers a great work environment with fast-paced, challenging and rewarding careers. Both GE & Safran are world leaders in the design and manufacture of aircraft engines, propulsion systems, & aircraft equipment. This could be your opportunity to join the exciting aviation industry!
We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
PTI will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen.
$65k-88k yearly est. Auto-Apply 25d ago
Mechanical Process Engineer
TTM 4.2
Eau Claire, WI jobs
TTM Technologies, Inc. - Publicly Traded US Company, NASDAQ (TTMI) - Top-5 Global Printed Circuit Board Manufacturer
TTM Technologies, Inc. is a leading global manufacturer of technology products, including mission systems, radio frequency (“RF”) components, RF microwave/microelectronic assemblies, and technologically advanced printed circuit boards (“PCB”s). TTM stands for time-to-market, representing how TTM's time-critical, one-stop design, engineering and manufacturing services enable customers to reduce the time required to develop new products and bring them to market.
Additional information can be found at ***********
Join TTM Technologies as we grow! We're opening a new Eau Claire facility and looking for talented team members. You'll start with comprehensive training at our Chippewa Falls location, with the potential opportunity to transition to our new Eau Claire site. Be part of our expansion and make an impact from the start!
The Process Manufacturing Engineer is responsible for developing, implementing, and maintaining new and improved manufacturing systems to improve methods as it relates to printed circuit boards. Area of focus will be thin film coating, photoimaging, and chemical conversion of materials used to produce multi-layer printed circuit boards.
Duties and Responsibilities
:
Responsible for developing, implementing, and maintaining new and/or improved manufacturing systems, processes, methods, equipment, strategies, technologies, and facilities in order to improve manufacturability and produce products within a reasonable schedule and budget.
Ensures cost-effective design, installation, and method of monitoring and modifying of manufacturing processes.
Resolve problems in processes and materials.
Evaluate alternative approaches to manufacturing if a product, as designed, cannot meet product requirements.
Interface with internal and external customers, suppliers and/or equipment vendors to resolve manufacturing issues.
Develop budgets for capital equipment, product start-up and development projects.
Develop project plans for implementation of new processes, existing process modification, capacity improvements and throughput enhancements.
Perform cost/benefit analysis on new and existing manufacturing process improvement opportunities.
Perform capacity and capability analysis on manufacturing processes.
Develop experiments to diagnose and correct manufacturing problems utilizing statistically valid methodologies.
Identify yield improvement opportunities and leads the development of action plans to improve yields.
Perform defect characterization analysis to construct root cause effect relationships for defect reduction leading to yield enhancements.
Provide critical process/parameters data for FMEA manufacturing tables.
Participate in project implementation and defect reduction teams.
Provide investigation, analysis, containment and solutions for yield excursions.
Document all tests and process changes - permanent and temporary - through a change control system that is ISO compliant.
Education and Experience
:
Bachelor's degree in Engineering or related field or equivalent experience preferred.
5 years' experience in related field. Printed Circuit board or similar Electronic Manufacturing preferred.
Experience in value-add manufacturing with chemical, mechanical, imaging, or polymer processes is preferred
Adept in using MES systems, Microsoft Word, Excel, and a working knowledge Minitab, PowerPoint, Microsoft Access and Microsoft Project is preferred.
Familiar with world class manufacturing principles of: DOE, FMEA, Jidoka/Andon, TPM, 6S. Experience with machine automation and Factory 4.0 concepts is preferred.
Highly technical communications capabilities are necessary to successfully exchange with suppliers, customers, and internal functions
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Compensation and Benefits:
TTM offers a variety of health and well-being benefit programs. Benefit options include medical, dental, vision, 401K, Flexible Spending Account, Health Savings Account, accident benefits, life insurance, disability benefits, paid vacation & holidays. Benefits are available 1st of the month following date of hire.
Compensation for roles at TTM Technologies varies depending on a wide array of factors including but not limited to the specific office location, role, skill set and level of experience. As required by local law, TTM provides a reasonable range of compensation for roles that my be hired in New York, California and Colorado. For California-based roles, compensation ranges are based upon specific physical locations.
Export Statement:
Must comply with TTM Export Control Policies and Procedures and all applicable laws including ITAR, EAR and OFAC including but not limited to: a) being able to identify ITAR product on the manufacturing floor and understand that access to these products and related technical data is restricted to only US Citizens and US Permanent Residents; b) recognition of Foreign Person visitors by badge differentiation; c) understand and follow authorization procedures for bringing foreign visitors into facilities (VAL); d) understand the Export and ITAR requirements for shipments leaving the US; e) manage vendor approvals for ITAR manufacturing and services.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
$57k-73k yearly est. Auto-Apply 22d ago
Process Engineer - Biological Manufacturing Upstream & Downstream
Zoetis 4.9
Lincoln, NE jobs
Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.
At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.
Benefits Include:
4 weeks accrued paid vacation and 13 paid holidays.
401(k) match with company profit sharing.
Tuition reimbursement and Student Loan repayment program.
Great Health, personal, and family benefits starting day 1.
Position Summary
Monitor monoclonal antibody (mAb) batch performance and investigate outliers. Assist with deviation resolution and effective CAPA implementation. Lead and drive technical improvements in our monoclonal antibody (mAb) manufacturing processing area and troubleshoot complex technical challenges.
Hours: 1st Shift with on-call rotation. Weekends and holiday may be needed to support business needs.
Position Responsibilities
Looking for a strong technical leader in biologic manufacturing to drive technical improvements in our monoclonal antibody (mAb) manufacturing processing area and troubleshoot complex technical challenges.
Lead technical discussions between area team leaders and their respective team, small scale process experts, and quality assurance delegates to assist with deviation closing.
Participate in CAPA implementation and manage effectiveness check.
Monitor and report of key process indicators (KPI).
Investigate outliers and implement lasting changes to drive process efficiency and robustness.
Participate in the introduction of new production processes and site to site transfers in collaboration with Global Manufacturing Technology.
Maintain state of the art competence on technological developments within area of responsibility and recommend equipment and/or process enhancements that will provide improved efficiencies, safety, and a competitive advantage.
Draft and manage SOPs, batch records, and risk assessments.
Work cross-functionally with multiple teams to ensure mAbs delivers the highest quality products and provide the team with the tools, resources and technical support needed to achieve their goals.
Assist with technical projects within the mAb area.
Review automation recipes.
May be responsible for supervision of up to 4 colleagues.
Education and Experience
Degree in Biological Sciences, Chemical Engineering, Biochemistry, or in any relevant disciplines is required.
Expectation of minimal relevant experience requirement: Bachelor + 6 - 8 years, Master + 3 - 5 years, PhD + 1- 2 years
Technical Skills and Competencies Required
The ideal candidate would possess:
Experience with working in a GMP environment preferred.
Experience with mAb or biological production (upstream) and purification (downstream) at large scale or small scale.
Knowledge of quality system such as TrackWise is a plus.
Ability to engage and collaborate with others, and to lead projects.
Analytical driven with understanding of data trending and statistics.
Strong understanding of aseptic technique, cell culture, centrifugation, depth filtration, chromatography, tangential flow filtration and nanofiltration.
Knowledge in chromatography software such as AKTA Unicorn platform and other automation (e.g., Delta V) is a plus.
Demonstrated understanding of Lean Manufacturing concepts and principles preferred.
Excellent communication (written and oral) with attention to detail.
Self-starter, able to prioritize work on multiple concurrent projects and work efficiently with minimal guidance.
Strong computer, scientific, and organization skills.
Demonstrated record of working in a team environment.
Physical Position Requirements
Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations and biohazards: All of which Zoetis makes as safe as possible for the colleagues.
Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.
The colleague may be required to work greater than 40 hours per week, including weekends and holidays to support the business.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$65k-82k yearly est. Auto-Apply 35d ago
Manufacturing Engineering Technician
Precision Optics Corporation 3.9
Gardner, MA jobs
Full-time Description
Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data.
Principal Responsibilities
Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products.
Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions.
Assemble fragile and sensitive electro-mechanical and optical medical devices.
Train manufacturing staff on assembly methods/procedures.
Conduct experiments and record data in a laboratory environment; perform data analysis.
Collaborate directly with engineers, production operators, quality inspectors and management personnel.
Communicate technical issues clearly and effectively to engineering staff.
Establish and maintain stability of late-stage development programs and build activity.
Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.).
Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements.
Perform miscellaneous duties and projects as assigned and required.
Requirements
Training, Skills, Knowledge and/or Experience
3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products.
Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools.
General understanding of data collection, data reduction, and statistics.
Experience working in FDA QSR and ISO 13485 environments preferred.
Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel.
Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems.
Education Requirements
High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred.
Supervisory Responsibility
No supervisory responsibility.
Working Conditions
This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms.
Physical surroundings
This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.
PPE required when in controlled environment rooms.
Physical Effort
While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.
Travel
Limited, infrequent travel may be required.
Salary Description $22 - $32 / hour