Process Engineer jobs at Catalent Pharma Solutions - 378 jobs
Senior Engineer, Process Engineering
Astrazeneca 4.6
Redwood City, CA jobs
Expertise in equipment and manufacturing process, capability to support multiple process areas
3+ years of leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance
Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery
Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes.
Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area
Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of processengineering
. • Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance.
Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization.
Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency.
Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems
Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians
Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within processengineering area.
Participate in communications with relevant internal teams (e.g., regulatory) for management of change control.
Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements. Develop contacts across a range of departments and external groups acting as engineering representative. Equipment Management
Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness
Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management
Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation
Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business
Essential Requirements:
Bachelor's degree in Chemical or Mechanical Engineering
Minimum of 3 years relevant experience.
Breadth of experience to establish credibility with key stakeholders.
Industry experience in a GMP environment
Preferred Experience:
5 years of relevant experience
Large Capital project management and execution experience
Lean certification
Experience with automatic process controls
Root cause investigation training/ 6-simga
TPM experience
Experience with spray-drying technology
Experience with equipment maintenance
Experience with regulatory inspections and handling deviations
Experience working within cross-functional teams.
Has experience in change control, budget and project management, including a track record of driving continuous improvement initiatives.
Project management track record of delivering projects
Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps)
The annual base pay for this position ranges from $97,372 - $146,058. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
22-Dec-2025
Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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$97.4k-146.1k yearly 5d ago
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Senior Research Metallurgist
Deringer-Ney Inc. 3.8
Bloomfield, CT jobs
Title: Senior Research Metallurgist
The Senior Research Metallurgist provides technical expertise in areas of materials and processes in support of all areas of the company. Initiates and conducts new material, process, and product development; works directly with customers and potential customers to resolve technical problems; and assumes leadership of R&D during the absence of the R&D Manager.
Supervisory Responsibilities:
Yes
Duties/Responsibilities:
Initiate and conduct new product development, especially in the areas of new alloy formulation, materials processing and innovative use of all Deringer-Ney processes and materials.
Assist with day-to-day manufacturing problems related to materials and processing.
Take lead role in the development of innovative solutions to manufacturing problems.
Provide technical support to the Sales and Marketing departments.
Work directly with customers and prospects to select appropriate DNI products.
Perform detailed failure analyses for company, customers, and prospects.
Prepare well written, professional reports for both internal and external use.
Provide technical training, and support of, field sales personnel.
Maintain working knowledge of technological developments in both new and existing markets and keep upper management aware of potential impact of these changes.
Support new product development activities of others within the company.
Initiate continuous improvement and operational excellence programs within R&D and support similar programs within the organization.
ADDITIONAL RESPONSIBILITIES:
Supervise activities of R&D technician(s).
Undertake special projects as requested by the R&D Manager.
Develop and document new test methods to support improved product quality/ reliability.
Required Skills/Abilities:
Extensive technical understanding of company products and processes.
Well-developed interpersonal skills.
Excellent writing ability.
Able to prepare and make effective presentations to company employees and customers.
Experience & Education Requirements:
Minimum - BS degree in Metallurgical Engineering, Materials Engineering, or Materials Science and Engineering.
Extensive, demonstrated understanding of alloy development and material processing.
Demonstrated record of preparing high quality technical reports, whitepapers, manuscripts, or patents.
Required Experience:
BS + 12 years industrial research experience.
MS + 5 years industrial research experience; or
PhD + 1 year industrial experience
Outstanding candidates at lower experience levels may be considered for a Research Metallurgist position
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift 15 pounds at times.
Must be able to access and navigate each department at the organization's facilities.
$79k-111k yearly est. 5d ago
Project Quality Engineer
Delcath Systems 3.6
Queensbury, NY jobs
The Project Quality Engineer is responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations.
The Project Quality Engineer is responsible for providing quality project management and support for the company by working with the Senior Quality Assurance Manager to assure proper GMP compliance within Delcath Systems.
PRIMARY DUTIES AND RESPONSIBILITIES:
Project Management - lead continuous improvements projects.
Participate on new product design teams as the design quality assurance engineer.
Support design verification, process validation, software validation and test method validation.
Generate procedures, specifications, and labeling as required.
Support the Corrective Action and Preventive Action Program.
Support the Internal Audit Program through the performance of audits as required.
Support the Supplier Quality Program and perform on-site quality audits, as required.
Support external regulatory audits.
Understand and communicate component and finished product specification requirements.
Support the Management Review process to monitor and evaluate Quality System effectiveness.
Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required.
A minimum of Bachelor's degree in engineering or physical sciences is preferred.
A minimum of five or more years of experience in quality assurance, quality engineering, project management or related functions in an FDA regulated industry or ISO certified organization is required.
Must be team oriented, with the ability work well with diverse cross-functional teams.
Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.
$76k-97k yearly est. 1d ago
Manufacturing Technology Project Engineer
Deringer-Ney Inc. 3.8
Bloomfield, CT jobs
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
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
Senior Manufacturing Test Software Engineer (Python)
Red Oak Technologies 4.0
San Francisco, CA jobs
Manufacturing Test Engineering Manager (or Senior/Lead Test Engineer)
Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily.
This role is fully onsite in San Francisco, CA.
Position Overview
The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis.
The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing.
Key Responsibilities
Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing.
Serve as a working manager, providing technical leadership while contributing hands-on daily.
Mentor and train Test Engineers on both technical and soft skills.
Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives.
Collaborate with cross-functional teams on software development, verification, and validation for new product introductions.
Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization.
Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation.
Communicate project updates, risks, and recommendations to management and stakeholders.
Ensure timely completion of team deliverables and proactively address constraints or delays.
Support contract manufacturing facilities with occasional travel (less than 10%).
Work full-time onsite in San Francisco, CA.
Qualifications and Skills
Strong proficiency in Python development (minimum 5 years).
Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design.
Strong skills in debugging, programming, data collection, and data analysis.
Experience using project tracking tools such as Jira, Confluence, or equivalents.
Proven ability to deliver results in a fast-paced engineering environment.
Excellent organizational skills with the ability to manage multiple concurrent projects.
Demonstrated people management or technical leadership experience (3+ years preferred).
Experience working with high-precision electro-mechanical assemblies.
Preferred: Experience developing test software for high-volume production and test equipment.
Education
BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required.
MS degree preferred.
Additional Information
Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses.
This position is within an electrical component manufacturing environment (not medical devices).
About Red Oak Technologies
Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences.
Red Oak Core Values:
Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone
$109k-146k yearly est. 1d ago
Engineer III, Process
MSD Careers 4.6
Rockville, MD jobs
This position is responsible for leading the development, characterization and validation of manufacturing processes to produce biochemical assay plates and related consumables. This position may provide day to day guidance to others.
DUTIES AND RESPONSIBILITIES:
• Provide input to the management team to identify, develop, and execute departmental initiatives and strategies.
• Lead technical team(s) to accomplish project goals and manages/coordinates work of other team members.
• Enhance existing manufacturing processes and implement new manufacturing processes to ensure high quality production, reduced lot-to-lot variability, expanded product portfolio and enhancements to manufacturing capacity.
• Design, conduct, supervise and review process experiments on manufacturing and pilot scale equipment to determine the impact of material properties and process variables on product properties.
• Work with suppliers to improve product quality and lot-to-lot reproducibility of purchased raw materials.
• Collaborate with other departments to ensure peak product performance.
• Support the corporate validation effort as required for ISO certification and FDA approval.
• Write and review SOPs, validation protocols and validation reports.
• Document and present experimental results in accordance with company procedures.
• Specific duties may vary depending upon departmental requirements.
EXPERIENCE AND QUALIFICATIONS
• Bachelor's in chemical/biochemical engineering or a related field.
• Six to eight years related experience in manufacturing of instrumentation or related field.
• Experience in quality standards such as GMP, ISO 9001 and ISO 13485 is required.
• Supervisor experience is preferred.
KNOWLEDGE, SKILLS AND ABILITIES
• Expert knowledge of process development techniques (such as process optimization, process control, design of experiments) and statistical analysis.
• Expert knowledge of screen printing, assembly and coating techniques, fluid dispensing, drying/desiccation techniques, protein stabilization, electrochemiluminescence and image analysis techniques.
• Familiarity with assay development and QC techniques.
• Attention to detail with demonstrated commitment to excellence and performance.
• Strong analytical skills with the demonstrated ability to gather and evaluate complex data and information and develop a recommendation and plan of action.
• Ability to work independently, as an effective team member, and with all levels of the company.
• Demonstrated ability to move project tasks forward in an orderly and structured fashion.
• Excellent oral, written communication and interpersonal skills.
• Proficiency with the MS Office Suite (including MS Project) and Minitab.
• Demonstrated ability to multi-task and work productively in a demanding research environment with changing priorities.
• Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results.
Ability to travel locally.
PHYSICAL DEMANDS
This position requires the ability to communicate and exchange information, utilize manufacturing and laboratory equipment, and move about the office and manufacturing floor.
WORK ENVIRONMENT
This position will spend time in a Clean Room environment, with some travel between local office sites.
COMPENSATION SUMMARY:
The annual base salary for this position ranges from $101,400 to $154,650. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.
BENEFITS SUMMARY:
At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.
EEO/AA STATEMENT:
MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.
Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
$101.4k-154.7k yearly 47d 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. 36d 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 11d 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 14d 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. 7d 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. 6d 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 contractor 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/ preferred:
B.S. Mechanical or Electrical Engineering
Pay $30 - $41 / hour W2 depending on experience.
#INDENG
$30-41 hourly 3d ago
Process Engineer - Plasma Spray & HVOF
Propulsion Technologies International, Inc. 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 15d 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
#LI-KD1
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 12d 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
$22-32 hourly 60d+ ago
Manufacturing Engineering Technician
Precision Optics Corporation Inc. 3.9
Gardner, MA jobs
Job DescriptionDescription:
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.
$51k-67k yearly est. 23d ago
IT Manufacturing Engineer
Elanco 4.9
Indianapolis, IN jobs
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role:
As a IT Manufacturing Engineer at Elanco, you will be a key technical contributor to the digital heart of our production facilities. You will specialize in implementing and supporting our Manufacturing Execution Systems (MES) and Laboratory Execution Systems (LES). This hands-on role is the critical bridge between our physical manufacturing processes and the digital systems that control and document them, ensuring our operations are efficient, compliant, and reliable.
This includes four strategic priorities:
Pipeline Acceleration: Optimize the search and approval of high impact medicines with a focus on speed, cost and precision.
Manufacturing Excellence: Improve the efficiency, quality and consistency of core manufacturing processes, specifically execution and equipment effectiveness.
Sales Effectiveness: Simplify the process to find, trust and consume relevant customer insights that drive sales growth and improved engagement.
Productivity: Expand operating margin through efficiency by systematically reducing our operating expenses across the company, improving profitability.
Your Responsibilities:
System Design and Configuration: Contribute to the design and be responsible for the configuration and implementation of MES/LES solutions. This includes building and modifying electronic batch records (EBRs), system workflows, and configuring equipment integration based on defined requirements.
Process Optimization: Collaborate with operations and quality teams to analyze manufacturing and laboratory workflows. You will use MES/LES capabilities to help implement process improvements, reduce production cycle times, and enhance data integrity at the shop-floor level.
System Management and Support: Provide frontline technical support for MES and LES platforms. You will act as a key technical resource to troubleshoot and resolve system issues, ensuring high availability for our manufacturing and lab teams.
Integration: Assist with the integration between MES/LES and other critical systems, such as our ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data.
Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) for MES/LES enhancements and new implementations. You will be responsible for generating validation documentation and ensuring systems are maintained in a validated state, compliant with GxP and data integrity requirements.
Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities.
User Training and Enablement: Develop training materials and conduct training sessions to ensure that manufacturing and lab personnel are proficient in using the MES/LES systems effectively in their day-to-day roles.
What You Need to Succeed (Minimum Qualifications):
Educational Background: A Bachelor's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
Required Experience: 3+ years hands-on experience with the configuration, and support of an MES or LES platform (e.g., Werum PAS-X, Emerson Syncade, POMSnet).
Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry.
Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles.
Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and how they integrate with higher-level manufacturing systems.
Database and SQL Skills: Experience with SQL for data queries to support troubleshooting, data extraction, and report generation.
What Will Give You the Competitive Edge (Preferred Qualifications):
Problem-Solving: Strong analytical and troubleshooting skills, with the ability to systematically diagnose and resolve technical issues.
Process Analysis: A solid understanding of business process analysis and workflow design. Ability to read and interpret process maps and requirements documents.
Cross-Functional Collaboration: Good communication and interpersonal skills, with a proven ability to work effectively in a team environment with operators, scientists, and management.
Cloud Platform Proficiency: Familiarity with Public Cloud platforms, specifically Microsoft Azure or Google Cloud Platform (GCP), is a plus.
DevSecOps: Familiarity with the concepts of DevSecOps, including Continuous Integration/Continuous Delivery (CI/CD) and source control (Git), is desirable.
Communication Skills: Good verbal and written communication skills, with the ability to collaborate effectively within a technical team.
Additional Information:
Location: Global Headquarters- Indianapolis, IN (Hybrid environment)
Travel: Minimal
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
$50k-62k yearly est. Auto-Apply 18d ago
Process Engineer
Amneal Pharmaceuticals 4.6
Piscataway, NJ jobs
ProcessEngineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.
Essential Functions:
Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
Coordinate/oversee the development of new processes or troubleshoot existing ones
Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits
Additional Responsibilities:
Initiation of Change Controls and Planned Deviations when required
Education:
Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required
Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred
Experience:
2 years or more in Pharmaceutical/Manufacturing Industry
Skills:
Excellent verbal and written communication skills - Advanced
Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced
Specialized Knowledge:
Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.
The salary for this position ranges from $80,000 to $95,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
$80k-95k yearly Auto-Apply 42d ago
Process Engineer
Amneal Pharmaceuticals, Inc. 4.6
Piscataway, NJ jobs
ProcessEngineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.
Essential Functions:
* Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
* Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
* Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
* Coordinate/oversee the development of new processes or troubleshoot existing ones
* Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits
Additional Responsibilities:
* Initiation of Change Controls and Planned Deviations when required