R&D Senior Engineer II
Alpharetta, GA jobs
Job Title: R&D Senior Engineer II
Job Country: United States (US)
Here at Avanos Medical, we passionately believe in three things:
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.
At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit ***************
Essential Duties and Responsibilities:
The R&D Senior Engineer II plays a key role in Avanos' New Product Development (NPD) organization, contributing to the design, development, and commercialization of innovative medical devices that advance patient care. This position combines hands-on design ownership, strong technical problem-solving, and cross-functional collaboration to ensure products meet user needs, regulatory requirements, and business objectives.
The R&D Senior Engineer II is responsible for leading design workstreams within complex programs, mentoring junior engineers, and ensuring engineering excellence throughout the product development lifecycle.
Key Responsibilities:
Lead design and development activities for assigned subsystems or product components through all phases of the PDP.
Develop and refine 3D CAD models, detailed drawings, specifications, and tolerance analyses consistent with design control and DFM/DFA principles.
Conduct and document design reviews, FMEA, and risk assessments to ensure robust performance, reliability, and patient safety.
Collaborate with cross-functional partners (Systems, Quality, Regulatory, Clinical, Technical Operations, Project Head) to translate user needs and system requirements into actionable design inputs.
Support prototype builds, design verification and validation testing, and root cause analysis for design issues.
Apply sound engineering principles in areas such as mechanical design, fluidics, and electromechanical integration to develop effective solutions.
Work Technical Operations teams to ensure designs are manufacturable, cost-efficient, and scalable.
Mentor and provide technical guidance to junior engineers within the team.
Support intellectual property development through design innovation and technical documentation.
Your qualifications
Required:
B.S. degree in Mechanical, Biomedical, or related Engineering discipline.
6+ years of experience in medical device design and development.
Strong proficiency in 3D CAD (SolidWorks preferred), GD&T, and mechanical design fundamentals.
Demonstrated experience leading design efforts for Class II or III medical devices.
Solid understanding of risk management, verification/validation testing, and documentation best practices.
Proven ability to solve complex technical problems and drive projects to completion in a matrixed environment.
Excellent written and verbal communication skills, with attention to design documentation and traceability.
Preferred:
Experience with electromechanical systems, fluid delivery, or disposable/reusable medical device interfaces.
Working knowledge of materials selection, molding processes, or sterilization methods (EO, gamma, e-beam).
Experience collaborating with contract manufacturers or development partners.
Participation in IP generation or patent applications.
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Salary Range:
The anticipated average base pay range for this position is $104,000.00 - $121,000.00. In addition, this role is eligible for an attractive incentive compensation program and benefits. In specific locations, the pay range may vary from the base posted.
Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here
Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.
Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.
Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.
Avanos also offers the following:
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions
Principal Supplier Quality Engineer
Alpharetta, GA jobs
Job Title: Principal Supplier Quality Engineer
Job Country: United States (US)
Here at Avanos Medical, we passionately believe in three things:
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.
At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit ***************
Essential Duties and Responsibilities:
Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.This position provides technical leadership for Supplier Quality Management processes and activities. The primary purpose of this position is to implement, coordinate, support, and monitor activities related to the Global Supplier Quality Management (SQM) activities across Avanos. This position may also train R&D, Technical Quality, Operations, and other functions on the established processes and any enhancements as needed and perform other additional duties as assigned..
Key Responsibilities:
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements.
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers.
Establish and administer the supplier audit program for quality/regulatory compliance.
Maintain the Approved Supplier List (ASL).
Support the Global Supplier Review Board, including providing metrics for
supplier assessments.
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits.
Provide guidance as needed for corrective action required because of assessment findings.
Execute supplier audits in accordance with approved schedules.
Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes.
Contribute to the supplier qualification vetting process and perform supplier evaluations to ensure appropriate suppliers are being selected.
Continuously improve existing Supplier Quality Management Process to ensure compliance with regulatory requirements.
Develop, implement, and execute a system for conducting due diligence evaluations for supplier qualifications and acquisitions.
Provide auditing support during due diligence and integration activities as needed.
External Interface:
This role will primary interface externally with suppliers and with external auditors from Notify Bodies and Regulatory Agencies
Your qualifications
Required:
Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.
Preferred:
B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry.
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques.
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor
Strong project management skills
Ability to make reasonable decisions and be able to effectively justify them
Strong collaborative skills and customer service approach
Exceptional written, verbal, and presentation communication skills
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.
IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here.
Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.
Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.
Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.
Avanos also offers the following:
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions
Mechanical Engineer
Rice Lake, WI jobs
*About us* Thomas Precision has been a leading manufacturer of parts and service to the food processing industry since 1981. Located in scenic NW Wisconsin, we take pride in bringing quality products and service to our customers. We are currently seeking a full time Mechanical Engineer to join our growing team.
*Position Responsibilities*
* Investigate and evaluate new manufacturing product lines and related processes.
* Oversee all stages of new product & process development, including:
* New component and machine designs
* Manufacturing processes/techniques
* Manufacturing cost reduction
* Working directly with customers at their facilities to investigate new opportunities and test designs
* Provide troubleshooting and technical support to TPM customers, sales department, and manufacturing for existing components and machines.
* Develop and implement manufacturing automation projects.
* Up to 10% travel required.
*Qualifications*
* Excellent written and verbal communication skills.
* Ability to self-direct own work and manage projects to ensure they are technically sound and conform to scope, timeframe, and budget.
* Especially valued for this position would be knowledge/experience in:
* A production machining environment
* Material properties and analysis
* Castings, weldments, metal coatings
* Use of CAD software
* Some electrical, controls, and/or PLC experience a plus.
* The ability to work independently and directly with customers on-site and on the road to make engineering design and process decisions.
* A strong background of work related to mechanical or manufacturing engineering is preferred.
* A 4-year degree in Mechanical Engineering, Manufacturing Engineering, or equivalent is required.
* Please note: This is an on-site position. Remote or hybrid work arrangements are not available.
*Why work for us?*
We offer a competitive salary, great working environment, and full benefit package including: 401K with company match, PTO, 9 Paid Holidays, Health Insurance/HSA, FREE Dental , Company paid Short Term Disability, Life Insurance and Voluntary Benefits.
_We do not discriminate on the basis of race, religion, national origin, color, sex, age, veteran status, or disability. It is our intention that all qualified applications be given equal opportunity and that selection decisions are based on job-related factors._
Job Type: Full-time
Application Question(s):
* Are you willing to travel up to 10% of the time. Travel may include working in wet food processing environments.
* Please list 2-3 dates and times that you would be available for a preliminary phone interview.
Education:
* Bachelor's (Preferred)
Ability to Commute:
* Rice Lake, WI 54868 (Required)
Work Location: In person
Product Design Engineer
Syracuse, NY jobs
*Purpose:* To develop, lead and manage all aspects of mechanical design of HVAC product from conception through qualification within budget and time constraints, while maintaining continual improvement of existing products. *Responsibilities*: * Create, or oversee the creation of, mechanical parts, labels, artworks for printing, CNC programs for milling machines and plastic mold designs.
* Presents models, to include design specifications, to engineering group.
* Build prototypes; order parts from vendors.
* Release designs to production.
* Test and ensure designs meet customer expectations as well as appropriate agency standards while taking into consideration product and production costs.
* Perform dimensional tolerance analysis and basic stress calculations.
* Interface with sales, testing laboratories and suppliers for the development of new products.
* Work with Manufacturing Engineering team to create drawings required for manufacturing & assembly of product.
* Develop & design product to conform to customer requirements & specifications within given timeframe.
* Maintain design documentation. Create and maintain part library.
* Integrates PCBA design with mechanical design requirements.
*Hiring Requisites:*
*Education*: Bachelor's Degree in Mechanical Engineering.
*Experience*: 5+ years of experience in design engineering demonstrating ability to execute development of task from initial concept, rough design, analysis, manufacturing and qualification testing.
*Skills*: Working practical knowledge of electronic products. Familiarity with SolidWorks and AutoCAD. Ability to understand and explain complex technical problems. Demonstrate expertise in a variety of engineering concepts and practices as well as effective implementation of process improvements into engineered environment. Familiarity with regulatory agencies governing product lines and implementation of industry standards as set forth by UL, CSA. Plastic injection molding experience beneficial.
*Key Success Factors*:
* Quality & creativity of design work
* Accuracy, timeliness and thoroughness of records and reports
* Judgment exercised in problem solving
* Knowledge of and consistent enforcement of company policies
*Key Relationships:*
* *Reports to: Director of Engineering*
* Internal: Engineering, Manufacturing & Sales Team, Functional Support Leads
* External*:* ICM Customers & Suppliers
*ABOUT ICM CONTROLS*
ICM Controls is a leading, ISO Certified manufacturer of electronic controls specializing in the HVAC industry. We have achieved this position through product and process innovation that spans more than 30 years, and we strive to maintain this position through extensive capitalization, focusing on our greatest manufacturing strength: true vertical integration. The ICM Controls manufacturing plant, located in North Syracuse, NY, is one of the most vertically integrated facilities in the country.
Serving both the OEM and the aftermarket, our goal has been to provide our customers with the most technologically advanced products at the greatest value - without compromise in quality. The ability to quickly take a control from concept to prototype to production has become an ICM Controls trademark. We are proud to be American made, and ICM Controls employees are committed to customer satisfaction.
Job Type: Full-time
Pay: $90,000.00 - $115,000.00 per year
Benefits:
* 401(k) matching
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
Work Location: In person
Process Engineer
Aurora, OH jobs
We're a “safety first high performance” culture driven by a zero waste and zero defect mentality set out to enrich the lives of humans everywhere. As a leading vitamin and food supplement manufacturer, we carry on the legacy of our Founder who led us to reshape the category. We have grown our passionate Piping Rock Family as we've grown our business. We are growing quickly, join the Piping Rock family and grow your career.
As a Process Engineer, you'll be responsible for equipment re-design while implementing, controlling, and optimizing packaging/manufacturing processes and machinery to achieve organizational targets. You'll work hand in hand with Production and Engineering to help improve standards that enable high performing production processes in our facility. Additional responsibilities include defining equipment standards, leading process and benchmarking and reapplication, and building capability within teams to do technical troubleshooting and process improvement and understanding the Piping Rock Continuous Excellence program and the respective tools.
Responsibilities:
Analyze production loss data to identify and prioritize projects to be executed in factory's continuous improvement plan and develop technical mastery of the core production processes, driven by bottleneck/high losses. Lead v-curve analysis and balanced line flow studies and identify debottlenecking projects.
Initiate, lead, and modify process/improvements that will increase throughput, reduce scrap, improve quality, and eliminate losses. Implement LEAN manufacturing methods.
Drive and mobilize resources to conduct problem solving on systems or equipment through failure modes & effects analysis (FMEA) and other Six Sigma methodology.
Develop productivity standards, collect data to publish KPI and OEE reports.
Participate in planning, commissioning, and startup of new equipment/processes.
Creating and improving standards that enable sustainability of high preforming production processes and supporting training programs that develop high performing operators and technicians and.
Collaborating with technical experts, other functions, and other factories to create and replicate optimal solutions/best practices.
Establish operating parameters for each equipment by product to obtain reliable and efficient production
Responsible for working directly on the manufacturing lines and assisting mechanics during repairs to understand the process workflow.
Work schedule flexibility to overlap with other shifts as needed.
Other duties as assigned.
Qualifications:
Bachelor's degree in an engineering field, preferably Industrial and Systems Engineering
3+ years of project/ process management experience in a manufacturing, or packaging environment.
Or Associates degree in a technical field.
7+ years of project/ process management experience in a manufacturing, or packaging environment.
Preferred Skills:
Six Sigma or Lean certification.
Experience with process automation and control systems.
GMP environment a plus
Must be able to lift 30lbs
Must be able to stand for 8 hours
Must be able to work in a physically challenging environment.
We proudly offer: Medical, Dental, Vision, 401K with Company Match, Pet insurance and more!
We reward the hard work of our team members with fun and exciting company events, Summer Picnic, Festive Packages, Holiday Celebrations, and associate referral bonuses!
Founded in 2011, Piping Rock Health Products has gone on to win Long Island's Top Workplaces Award 6 years in a row & securing the spot as Top Supplement Manufacturing Company 2024 by Food Business Review! Supported by a group of vitamin visionaries with over 40 years of industry experience and a carefully curated team of talented associates. Piping Rock is a global vitamin and supplement manufacturer with an unwavering commitment to creating quality wellness products. We believe that family always comes first, and that the dedication of our associates is the key ingredient to our success.
We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines.
Piping Rock Health Products, INC is an Equal Opportunity Employer.
Senior Project Engineer
Kansas City, MO jobs
Senior Project Engineer - Commercial
Kansas City, MO
Are you the type of professional who puts just as much care into managing relationships as you do into managing projects and supporting your team? Are you equally skilled at explaining contracts as you are at scoping them? Are you ready to join a Commercial General Contractor that will help you thrive?
We're looking for a Senior Project Engineer to play a key role in the delivery of complex commercial projects, working closely with clients and the project team. That Senior Project Engineer could be you.
Why You'll Love Us
Competitive pay and a comprehensive benefits package
An engaging workplace and exciting projects that make an impact
Innovative and sustainable business practices that set us apart
A team that gets things done!
What You'll Do
Take ownership of quality control and assurance across commercial projects. Plan your work and work your plan, overcoming obstacles and driving projects forward with confidence and clarity. Manage RFIs, submittals, change orders, claims, and other critical documents. Support and lead coordination across the project team and serve as the main point of contact with subcontractors. Stay ahead on site documentation, changes, and cost implications while ensuring all safety protocols are followed. Mentor junior engineers and help grow the team.
A Little More About You
Minimum 5 years of related experience in commercial construction
Degree in Construction Management, Civil Engineering, or related field
Reliable, personable, and someone others enjoy working with
Strong leadership skills with the ability to mentor others
Excellent communication and relationship-building skills
Experience with construction software preferred
Ability to prioritize and manage time effectively
Strong decision-making skills, you'll often be the one making the final call
If you're ready to take on challenging, meaningful projects and grow with a team that values your expertise, let's build something extraordinary together.
Process Development Associate I
Boulder, CO jobs
This position resides in the Process Operations team in the Process Development department and drives robustness and consistency in the laboratory through execution and innovation of laboratory practices. They drive efficiencies in Process Development while maintaining ownership of the laboratory and systems. They will have the responsibility of being operations leads on projects with increasing ownership and collaboration within the department. Through defined roles and responsibilities, the process operations team will be subject matter experts (SMEs) on both the execution of processes as well as the systems in the laboratory.
The Process Development Associate supports and executes laboratory studies within the KBI Process Development organization at KBI under general supervision. The Process Development Associate is able to execute lab work, with documentation and reporting that is consistent with Process Development compliance and Quality standards. The Process Development Associate is able to author basic operational documents for routine unit operations within the laboratory organization. The Process Development Associate is capable of executing lab studies from written documents and applies standard scientific approaches to solving technical problems. The Process Development Associate may serve as the point of contact for a specific laboratory project. The Process Development Associate works under the general supervision of laboratory management with work reviewed for soundness and accuracy.
The Process Development Associate will have a basic understanding of Process Development methods/unit operations as well as scientific principles in order to execute lab studies. The Process Development Associate will have the ability to execute laboratory experiments from written/verbal instruction. Basic technical writing and communication skills are desired. Basic understanding of laboratory equipment and equipment maintenance are required. The Process Development Associate participates in process development meetings and technical investigations if needed.
Experience in various stirred tank fermentations (single-use and stainless), chromatography, precipitation, and filtration methods are highly preferred.
The Process Development Associate will assist in the evaluation, development and implementation of new technologies leading to process improvements and efficiency of operations. The Process Development Associate will identify and implement continuous operation improvement ideas as a major part of this role.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Auto-ApplyManufacturing Supervisor - 3rd Shift
Round Lake, IL jobs
This is where your work makes a difference.
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role at Baxter
3rd Shift: 11pm-7:30am
You will be responsible for implementing and supervising daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May monitor and control labor.
Your team
Baxter is focused on saving and sustaining lives by finding solutions to sophisticated problems. Every single day, the manufacturing team strives to create quality products for our customers-and are sometimes met with unforeseen issues to tackle. The high-caliber talent at Baxter meets these challenges head-on, as a team, to create products with the customer's needs top-of-mind.
We build relationships with each other to get work done.
We provide opportunities for you to continue to learn through training, conferences, certifications, and support for advanced degrees. Growth from role to role or level to level is encouraged and is supported by management to ensure employees are consistently engaged with their work.
What you'll be doing
Will provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
Responsible for supervising the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities -to meet customer requirements including deadlines and quality standards.
Audit, refine, and improve processes and equipment operation within the manufacturing areas. Drive to utilize resources and raw materials in the most efficient and productive manner possible.
Support and Emphasize the Safety and Quality commitments of the department.
Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress.
Facilitate and verify appropriate training for employees in the area.
Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
Represent the Company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
Provide a positive and equitable working environment emphasizing the Baxter.
Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.
Candidate should not be allergic to PENICILLIN or CEPHALOSPORINS
What you'll bring
HS diploma or equivalent required and 2 years manufacturing and 1 year of leadership experience.
Bachelor's degree and 1 year of experience.
Bachelor's degree required for ongoing career progression
Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment
In-depth process knowledge of related manufacturing equipment and processes.
good understanding and/or hands-on familiarity with the principles of lean manufacturing.
Ability to manage multiple priorities in a manufacturing plant setting.
Ability to interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues. Strong assessment and troubleshooting skills.
Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions
Strong professional writing skills and ability to prepare technical reports.
Ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
Ability to respond to detailed inquiries, and present information to groups and senior management.
May be required to supervise multiple groups.
Ability to work weekends and overtime when necessary is required.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $64,000 - $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Auto-ApplyManufacturing Supervisor- Night Shift
Bangor, PA jobs
Job DescriptionJoin our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. Currently, we are looking for a Manufacturing Supervisor.
As a key player in our organization, you will lead a manufacturing shift within our Bangor Manufacturing facility but be open to assist when required at our Stroudsburg facility. We are looking for a detail-oriented individual with strong leadership skills to drive operational excellence and foster team success.
BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA, and Scarborough, Canada.
Why should you join BioSpectra, Inc.?
Support our current customers who are the top 25 pharmaceutical companies in the world
Develop your career with a growing organization with ample opportunities for professional and personal development
Comprehensive Benefits Package (Medical, Dental, Vision, Company paid Life Insurance, Tuition Reimbursement)
401K Retirement Savings Plan - Company matches $2 per $1 of employee contribution on the first 4%
Excellent Paid Time Off Programs include vacation, sick, & personal time, plus paid holidays
Job Summary:
The Manufacturing Supervisor leads their team to accomplish the safety, quality, delivery and cost objectives of the manufacturing department. A supervisor reviews the daily production schedule, assigns work to their team, coordinates plant activities, ensures their team is trained and inspects chemical operator activity throughout the shift. Responsible for ensuring finished goods meet the production schedule and are in compliance with quality standards set for the facility. Leads by example and holds their team accountable for performance/results.
Essential Duties and Responsibilities:
Ensures team compliance with all current quality/cGMP and safety systems
Tracks, records and reports production data / KPI's on a daily basis.
Leads shift change meeting. Clearly communicates management priorities to team.
Maintains operational/batch data. Reads and analyzes charts, work orders or production schedules to determine production requirements.
Ensures new employees are trained, coached and evaluated.
Continuously assesses team performance on production floor and verifies compliance with cGMP/SOP requirements.
Ensures team members are trained, coached and developed to maintain coverage of critical tasks/functions in support of manufacturing operations.
Maintains training records for team. Schedules/facilitates training as required.
Executes daily production schedule as planned.
Initiates discrepancies as they occur and provides input on root cause and preventative actions.
Consults with Manufacturing Department Managers to coordinate operations and activities within and between departments.
Confers with management and/or subordinates to resolve worker problems and complaints.
Reviews and provides feedback for SOP/TOI revision documents.
Inspects materials, products or equipment to detect defects or malfunctions.
Routinely inspects documentation, processing rooms, equipment and finished good packaging during their shift to ensure compliance with cGMP manufacturing.
Monitors gauges, dials, and other indicators to ensure operations conform to production or processing standards.
Sets up and adjusts machines and equipment.
Monitors production area and enforces safety or sanitation regulations.
Inspects process rooms
Conducts batch record review and reconciliation.
Completes work order forms.
Utilize ERP system to issue, track and record manufacturing operation.
Other duties may be assigned as deemed appropriate by management
Qualifications:
High School diploma or equivalent.
Minimum of two years of supervisory experience in the chemical manufacturing industry: candidates with less experience may be selected at the discretion of management.
Demonstrated ability to lead and supervise employees to achieve production goals while ensuring that quality, regulatory, safety, and environmental requirements are met.
Capability to lead, coach, inspire, and motivate employees to develop effective teamwork and achieve outstanding performance standards.
Demonstrated capabilities to diagnose and solve problems, assess situations and take appropriate actions, make decisions effectively, and communicate to employees at all levels of the organization.
Mechanical reasoning and critical thinking skills required in order to troubleshoot chemical manufacturing process.
Proficient with ERP system use.
Proficient in Microsoft Office (Excel, Outlook, PowerPoint, Word)
Must be able to read, write, speak, and understand English.
Work Hours:
Exempt Position
Shift: 12-Hour Alternating 3 days on/3 days off (7:30pm-8:00am)
Minimum of 40-45 Hours Week, or other agreed upon documented schedule
Ability and willingness to work from all BioSpectra facilities- Primary Location: Bangor, PA
If you are ready to take on a challenging role, make an impact, and grow with a dynamic company that values innovation and quality, this position is for you! Apply now to be a part of our dedicated team and contribute to our ongoing success!
Manufacturing Engineering Technician - Machining (M - F 2:30PM-11:00PM CST)
West Milwaukee, WI jobs
SummaryThe Technician role involves the support for manufacturing machining operations of X-ray Tube components on 2nd shift (2:30PM-11:00PM). Duties include technical support of machining and tool grind operations, non-conforming material review and disposition, calibration, and documentation of fixturing, equipment, and processes. Must be able to drive continuous improvement and support Engineering and Manufacturing initiatives.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities
Knowledge and understanding of production processes, work instructions, documentation configuration control, non-conforming & rework documentation requirements and operating within them to ensure that a component conforms to its specification.
In-depth knowledge and compliance with the GE Healthcare (GEHC) Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, applicable laws, and regulations as they apply to this job type / position.
Provide technical assistance to production associates.
Develop and execute technical training as required.
Interface with other departments in the execution of duties to ensure the orderly flow of material and information.
Utilize basic technical communications throughout the new product cycle to improve internal models and/or externally sourced components in terms of system performance, reliability, functionality, and serviceability.
Provide evaluation, constructive feedback, and leadership in the development of internal and external engineering, manufacturing, or service documentation.
Provide strong individual contributions in the context of achieving team goals.
Comply with Environmental, health, and safety (EHS) regulations and policies and complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Perform trouble shooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution, including analysis and disposition of non-conforming material.
This role requires onsite attendance.
Required Qualification
Associate degree, or a High School diploma and minimum 5 years technical experience.
Proficiency to logically troubleshoot at subsystem and system level, using identifiable problem-solving techniques.
Demonstrated experience supporting production processes.
Proficiency to understand and interpret basic written technical information.
Demonstrated ability to work well with limited direction and information.
Desired Qualification
Bachelor's degree in Manufacturing, Engineering or Technology related fields.
Greater than 5 years experience in a manufacturing machining environment.
Strong technical knowledge in CNC machining, tooling, and measurement systems.
Demonstrated ability to write concise technical specifications and train production associates in process changes.
Demonstrates initiative and desire to improve production processes.
Demonstrates adaptability and flexibility, being open to change and responding to new information, changing priorities, unexpected circumstances, and changes in volume/ processes.
Experience working in a regulated industry Experience working with GE Healthcare's QMS requirements.
#LI- ONSITE
#LI-WI
We will not sponsor individuals for employment visas, now or in the future, for this job opening. Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare 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.
GE HealthCare 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 (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Auto-ApplyManufacturing Engineering Technician - Machining (M - F 2:30PM-11:00PM CST)
West Milwaukee, WI jobs
The Technician role involves the support for manufacturing machining operations of X-ray Tube components on 2nd shift (2:30PM-11:00PM). Duties include technical support of machining and tool grind operations, non-conforming material review and disposition, calibration, and documentation of fixturing, equipment, and processes. Must be able to drive continuous improvement and support Engineering and Manufacturing initiatives.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Responsibilities
* Knowledge and understanding of production processes, work instructions, documentation configuration control, non-conforming & rework documentation requirements and operating within them to ensure that a component conforms to its specification.
* In-depth knowledge and compliance with the GE Healthcare (GEHC) Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, applicable laws, and regulations as they apply to this job type / position.
* Provide technical assistance to production associates.
* Develop and execute technical training as required.
* Interface with other departments in the execution of duties to ensure the orderly flow of material and information.
* Utilize basic technical communications throughout the new product cycle to improve internal models and/or externally sourced components in terms of system performance, reliability, functionality, and serviceability.
* Provide evaluation, constructive feedback, and leadership in the development of internal and external engineering, manufacturing, or service documentation.
* Provide strong individual contributions in the context of achieving team goals.
* Comply with Environmental, health, and safety (EHS) regulations and policies and complete all planned Quality & Compliance training within the defined deadlines.
* Identify and report any quality or compliance concerns and take immediate corrective action as required.
* Perform trouble shooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution, including analysis and disposition of non-conforming material.
* This role requires onsite attendance.
Required Qualification
* Associate degree, or a High School diploma and minimum 5 years technical experience.
* Proficiency to logically troubleshoot at subsystem and system level, using identifiable problem-solving techniques.
* Demonstrated experience supporting production processes.
* Proficiency to understand and interpret basic written technical information.
* Demonstrated ability to work well with limited direction and information.
Desired Qualification
* Bachelor's degree in Manufacturing, Engineering or Technology related fields.
* Greater than 5 years experience in a manufacturing machining environment.
* Strong technical knowledge in CNC machining, tooling, and measurement systems.
* Demonstrated ability to write concise technical specifications and train production associates in process changes.
* Demonstrates initiative and desire to improve production processes.
* Demonstrates adaptability and flexibility, being open to change and responding to new information, changing priorities, unexpected circumstances, and changes in volume/ processes.
* Experience working in a regulated industry Experience working with GE Healthcare's QMS requirements.
#LI- ONSITE
#LI-WI
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare 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.
GE HealthCare 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 (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Manufacturing Lead
Crystal Lake, IL jobs
Cooking Solutions Lead
Schedule: Monday - Friday 1:00 pm - 9:30 pm
Compensation: $17.00-19.00 /hr plus $2.50 shift differential
AFC is seeking a skilled Cooking Solutions Fabricator Lead to join our team. The successful candidate will be responsible for assisting workers in the fabrication of specialty lightweight food belts and fabric pieces in the Quick Serve Restaurant line of business. The ideal candidate should have experience in operating heat sealing machines and be able to work in a fast-paced environment.
Responsibilities:
Works at different workstations as production needs require and as directed by the supervisor.
Good working knowledge of quality control and attention to detail.
Maintains work area, lightly cleaning as necessary.
Oversees the daily activities required to process the current production jobs, ensuring safety throughout the process
Promotes a positive team environment.
Suggest process improvements and be a change agent, following through when change is necessary
Ensures the department's work environment and work processes are safe, training employees in the company's established processes
Escalates any safety, quality, production or any issue that impacts production to the supervisor in a timely manner.
Support, clearly communicate, and enforce company policies and initiatives
Correctly completes all inventory transactions in the ERP system.
What You'll Bring:
High school diploma or GED
Two or more years related experience and/or training
Experience in operating heat sealer, hand sealer, four-corner machine, and die cutter.
Why Join AFC?
Stability & Growth: Industry leader with over 30 years of proven success
Full Benefits (Medical, Dental, Vision) - starting 1st of the month after 30 days
401(k) with company match
Generous PTO & 10 Paid Holidays
Annual Safety Shoe & Gym Reimbursement
Tuition Reimbursement & In-House Training (AFC University)
$2,000 Referral Bonus Program
About Us
AFC Materials Group, headquartered in Lake in the Hills, IL, is a global leader in high-temperature and non-stick composite solutions. Since 1988, we've partnered with OEMs, distributors, and end users to solve complex production challenges through expert coating, converting, and fabrication capabilities. For over 30 years, we've built a reputation on innovation, reliability, and a strong commitment to our people and customers. Join a team where growth, quality, and forward thinking are at the core of what we do.
AFC is an Equal Opportunity Employer, including disability/vets
AFC is a Drug-free workplace
Manufacturing Lead
Lake in the Hills, IL jobs
Job DescriptionDescription:
Cooking Solutions Lead
Schedule: Monday - Friday 1:00 pm - 9:30 pm
Compensation: $17.00-19.00 /hr plus $2.50 shift differential
AFC is seeking a skilled Cooking Solutions Fabricator Lead to join our team. The successful candidate will be responsible for assisting workers in the fabrication of specialty lightweight food belts and fabric pieces in the Quick Serve Restaurant line of business. The ideal candidate should have experience in operating heat sealing machines and be able to work in a fast-paced environment.
Responsibilities:
Works at different workstations as production needs require and as directed by the supervisor.
Good working knowledge of quality control and attention to detail.
Maintains work area, lightly cleaning as necessary.
Oversees the daily activities required to process the current production jobs, ensuring safety throughout the process
Promotes a positive team environment.
Suggest process improvements and be a change agent, following through when change is necessary
Ensures the department's work environment and work processes are safe, training employees in the company's established processes
Escalates any safety, quality, production or any issue that impacts production to the supervisor in a timely manner.
Support, clearly communicate, and enforce company policies and initiatives
Correctly completes all inventory transactions in the ERP system.
What You'll Bring:
High school diploma or GED
Two or more years related experience and/or training
Experience in operating heat sealer, hand sealer, four-corner machine, and die cutter.
Why Join AFC?
Stability & Growth: Industry leader with over 30 years of proven success
Full Benefits (Medical, Dental, Vision) - starting 1st of the month after 30 days
401(k) with company match
Generous PTO & 10 Paid Holidays
Annual Safety Shoe & Gym Reimbursement
Tuition Reimbursement & In-House Training (AFC University)
$2,000 Referral Bonus Program
About Us
AFC Materials Group, headquartered in Lake in the Hills, IL, is a global leader in high-temperature and non-stick composite solutions. Since 1988, we've partnered with OEMs, distributors, and end users to solve complex production challenges through expert coating, converting, and fabrication capabilities. For over 30 years, we've built a reputation on innovation, reliability, and a strong commitment to our people and customers. Join a team where growth, quality, and forward thinking are at the core of what we do.
AFC is an Equal Opportunity Employer, including disability/vets
AFC is a Drug-free workplace
Requirements:
Manufacturing Lead
Lake in the Hills, IL jobs
Full-time Description
Cooking Solutions Lead
Schedule: Monday - Friday 1:00 pm - 9:30 pm
Compensation: $17.00-19.00 /hr plus $2.50 shift differential
AFC is seeking a skilled Cooking Solutions Fabricator Lead to join our team. The successful candidate will be responsible for assisting workers in the fabrication of specialty lightweight food belts and fabric pieces in the Quick Serve Restaurant line of business. The ideal candidate should have experience in operating heat sealing machines and be able to work in a fast-paced environment.
Responsibilities:
Works at different workstations as production needs require and as directed by the supervisor.
Good working knowledge of quality control and attention to detail.
Maintains work area, lightly cleaning as necessary.
Oversees the daily activities required to process the current production jobs, ensuring safety throughout the process
Promotes a positive team environment.
Suggest process improvements and be a change agent, following through when change is necessary
Ensures the department's work environment and work processes are safe, training employees in the company's established processes
Escalates any safety, quality, production or any issue that impacts production to the supervisor in a timely manner.
Support, clearly communicate, and enforce company policies and initiatives
Correctly completes all inventory transactions in the ERP system.
What You'll Bring:
High school diploma or GED
Two or more years related experience and/or training
Experience in operating heat sealer, hand sealer, four-corner machine, and die cutter.
Why Join AFC?
Stability & Growth: Industry leader with over 30 years of proven success
Full Benefits (Medical, Dental, Vision) - starting 1st of the month after 30 days
401(k) with company match
Generous PTO & 10 Paid Holidays
Annual Safety Shoe & Gym Reimbursement
Tuition Reimbursement & In-House Training (AFC University)
$2,000 Referral Bonus Program
About Us
AFC Materials Group, headquartered in Lake in the Hills, IL, is a global leader in high-temperature and non-stick composite solutions. Since 1988, we've partnered with OEMs, distributors, and end users to solve complex production challenges through expert coating, converting, and fabrication capabilities. For over 30 years, we've built a reputation on innovation, reliability, and a strong commitment to our people and customers. Join a team where growth, quality, and forward thinking are at the core of what we do.
AFC is an Equal Opportunity Employer, including disability/vets
AFC is a Drug-free workplace
Supervisor, Manufacturing Support
Durham, NC jobs
The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (Supervisor) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment.
A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities.
The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers).
Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities.
The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that all deviations/events are documented and escalated according to KBI internal notification processes.
The Sr. Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics.
Position Responsibilities
Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution.
Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology.
Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders.
Ensure timely corrections to batch documentation and logbooks.
Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
Author, train, review manufacturing procedures
Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed.
Position Requirements
Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent.
Sr. Supervisor
Bachelor's degree in a related scientific or engineering discipline and 8 years' experience in related cGMP manufacturing operations; or high school degree and 12 years' experience, or equivalent.
2+ years prior leadership/supervisory experience.
Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred.
Experience in single-use platform technology is preferred.
For Supervisor, prior experience in a leadership/supervisory role is preferred.
Knowledge of quality systems and regulatory expectations is preferred.
Excellent written and verbal communication skills are required.
Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor
Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
MS Office, ERP, EDMS, production equipment software, other
Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Auto-ApplyManufacturing Engineering - Automation Technician - 1st Shift
Sheboygan, WI jobs
Duties & Responsibilities: * Ability to integrate robotics, vision systems, part feeders, PLC's, etc. into an automated production cell * Ability to layout and build electrical panels/equipment in a neat and orderly manner * Drive continuous improvement activity on existing automated manufacturing equipment (upgrading controls, rewiring/replacing control panels, and integration of new equipment)
* Partner with maintenance technicians to troubleshoot and correct equipment issues on the manufacturing floor
* Create new electrical schematics and updated existing schematics as needed
* Implement safety improvements to machines such as light curtains, interlocked guards, and ergonomic operator interface buttons
* Provides input pertaining to the development of functional specifications for new equipment builds. Partners with manufacturing engineers and equipment vendors on best practices
* Perform additional responsibilities as requested to achieve business objectives
Qualifications:
* High school diploma
* Minimum Associates degree in electronics, electromechanical or controls related field.
* 3 years of experience in manufacturing
* High level of proficiency with troubleshooting and programming of PLC's (Omron experience is a plus)
* High level of proficiency with implementation and programming of HMIs, motion control drives, vision systems, and Robotics
* High Level of proficiency with PC Based systems including networking systems
* Must be able to lift up to 40 pounds
Competitive Pay & Benefits:
* Paid vacation and 11 paid holidays
* Medical, dental, life, and disability insurance
* HSA and FSA accounts
* 401k with company matching and profit sharing
* Tuition reimbursement
Standards Engineer (Civil) II | T&D
Valle, AZ jobs
Arizona Public Service generates reliable, affordable and clean energy for 2.7 million Arizonans. Our service territory stretches across the state, from the border town of Douglas to the vistas of the Grand Canyon, from the solar fields of Gila Bend to the ponderosa pines of Payson. As the state's largest and longest-serving energy provider, our more than 6,000 dedicated employees power our vision of creating a sustainable energy future for Arizona.
Since our founding in 1886, APS has demonstrated a strong commitment to our customers in one of the country's fastest growing states, earning a reputation for customer satisfaction, shareholder value, operational excellence and business integrity.
Our present and future success depends on the creative and dedicated people of our company who demonstrate the principles outlined in the APS Promise: Design for Tomorrow, Empower Each Other and Succeed Together.
Summary
We are seeking a skilled and motivated T&D Standards Engineer (Civil) II/III to support the safe, reliable, and efficient construction, operation, and maintenance of our Transmission & Distribution (T&D) systems. In this role, you will apply your civil engineering expertise to moderate-scale engineering and construction projects, contributing to the development and enhancement of T&D standards and practices.
Key responsibilities include creating and maintaining construction standards and material specifications, conducting engineering analyses, evaluating materials and failed components, and supporting internal design and construction teams. You'll play an active role in identifying improvement opportunities across T&D design and construction processes, and will have increasing responsibility for technical decisions, guidance, and customer engagement.
The ideal candidate is detail-oriented, collaborative, and proactive in staying informed on industry trends and emerging technologies. Occasional after-hours support may be required.
Minimum Requirements
Engineer II
A four-year Bachelors degree in an engineering discipline or related applied science discipline (see approved list) from an ABET accredited institution, an International Engineering Alliance (IEA) recognized institution or an ABET Mutual Recognition Agreement (MRA) plus two (2) years working experience in Engineering-related positions.
Engineer III
A four-year Bachelors degree in an engineering discipline or related applied science discipline (see approved list) from an ABET accredited institution, an International Engineering Alliance (IEA) recognized institution or an ABET Mutual Recognition Agreement (MRA) plus five (5) years working experience in Engineering-related positions.
Approved Engineering degrees:
Materials Science/Metallurgy, Physics, Chemistry, Nuclear, Electrical, Mechanical, Civil, Electronics, Computer Science, Environmental, Chemical, Structural.
(A four-year bachelor of Engineering Technology degree is not considered an automatic equivalent for a B.S. degree in Engineering. A review of the degree program curriculum must be completed by Engineering department management.)
Preferred Special Skills, Knowledge or Qualifications:
Civil/Structural Engineering Degree.
Experience in structural loading analysis using O-Calc or other similar software programs.
Ability to apply good construction, operating and engineering practices while adhering to the APS safety rules and company policies.
Good oral and written communications skills.
Major Accountabilities
1) Analyzes and prepares a variety of data, technical reviews and evaluations, trend analyses, short to long-range technology assessments, products and services, investigations, product/specification verifications to aid decision making. May present findings to a diverse group of management, internal staff, customers, vendors, etc.
2) Identifies, communicates and advocates resolution of technical concerns while adhering to sound engineering principles during evaluation / resolution of the conditions. Challenges conditions and decisions when needed to ensure T&D Standards, engineering designs, project controls and oversight of work has high technical quality, is cost effective, in compliance with established standards, codes and regulations, maintains future reliability, satisfies customer requirements, budget and schedules to meet or exceed all reasonable or agreed upon customer service levels.
3) Interfaces with customers or cross organizational team members to assess their needs, determine the scope of the project, obtain necessary data to make key decisions which may require consultation with external or internal customers or employees.
4) May provide oversight of engineering technical programs by managing the program requirements, working with cross organizational partners, reviewing and internalizing operating experience and coordinating corrective actions to ensure engineering program elements continue to meet T&D standards.
5) Provides support for projects and modifications that will increase operating efficiency. May review design and documentation of projects to ensure compliance with design specifications, schedules and any regulatory requirements.
6) Plans, coordinates, sets priorities, and applies resources on moderate projects or processes.
7) Takes initiative to eliminate barriers and uses resources to ensure desired results.
8) Checks and reviews standard analysis, evaluations, and investigations of others.
9) Provides technical guidance and leadership to less experienced engineers.
10) Remains cognizant of current technology and engineering developments as well as industry and competitive developments.
11) Maintains high individual level of engineering technical capabilities and expertise by formal education, self-study, and awareness of technology advances.
Export Compliance / EEO Statement This position may require access to and/or use of information subject to control under the Department of Energy's Part 810 Regulations (10 CFR Part 810), the Export Administration Regulations (EAR) (15 CFR Parts 730 through 774), or the International Traffic in Arms Regulations (ITAR) (22 CFR Chapter I, Subchapter M Part 120) (collectively, 'U.S. Export Control Laws'). Therefore, some positions may require applicants to be a U.S. person, which is defined as a U.S. Citizen, a U.S. Lawful Permanent Resident (i.e. 'Green Card Holder'), a Political Asylee, or a Refugee under the U.S. Export Control Laws. All applicants will be required to confirm their U.S. person or non-US person status. All information collected in this regard will only be used to ensure compliance with U.S. Export Control Laws, and will be used in full compliance with all applicable laws prohibiting discrimination on the basis of national origin and other factors. For positions at Palo Verde Nuclear Generating Stations (PVNGS) all openings will require applicants to be a U.S. person.
Pinnacle West Capital Corporation and its subsidiaries and affiliates ('Pinnacle West') maintain a continuing policy of nondiscrimination in employment. It is our policy to provide equal opportunity in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations. This policy of nondiscrimination shall include, but not be limited to, recruiting, hiring, promoting, compensating, reassigning, demoting, transferring, laying off, recalling, terminating employment, and training for all positions without regard to race, color, religion, disability, age, national origin, gender, gender identity, sexual orientation, marital status, protected veteran status, or any other classification or characteristic protected by law.
For more information on applicable equal employment regulations, please refer to EEO is the Law poster. Federal law requires all employers to verify the identity and employment eligibility of every person hired to work in the United States, refer to E-Verify poster. View the employee rights and responsibilities under the Family and Medical Leave Act (FMLA).
In compliance with the Drug Free Workplace Act of 1988, the Company is committed to a work environment that is free from the effects of alcohol and controlled substances, and free from the abuse or inappropriate use of prescribed and over-the-counter medications. The Company requires employees to be subject to drug and alcohol testing that is job-related and consistent with business necessity, regulatory requirements and applicable laws.
Hybrid: Employees in hybrid roles work both in their home offices (virtually) and alongside their colleagues (in person).
In order for employees to build strong relationships and to promote meaningful in-person interactions, hybrid employees are expected to work about 40% of their time in-person at an APS or other (non-home office) location.
*Employees are expected to reside in Arizona (or New Mexico for Four Corners-based employees).
*Working from a home office requires adequate technology and an appropriate ergonomic set up.
*Role types are subject to change based on business need
Principal Optical Engineer
Jupiter, FL jobs
We are seeking to recruit a Principal Optical Engineer for our location in Jupiter, Florida.
Auto-ApplySenior Manufacturing Engineering Technician - 3rd Shift
Roswell, GA jobs
As a Senior Manufacturing Engineering Technician on the 3rd shift in our climate-controlled manufacturing area, you'll work with your own tool box (provided by IDEXX). You will have your own assigned desk, computer and cellphone. Our manufacturing is a dry plant and boiler-free environment. It's a medical device facility, it's very clean - you won't get dirty!
Details:
3rd Shift
Monday to Friday
9:30pm - 6:00am
Benefits:
Shift differential $3/hour
$35.50/hr base pay with flexibility depending on skills and experience
Paid Time Off
401K Matching
Discounted Stock Purchasing
Yearly Merit Increases
Yearly Bonus
$1000 credit to HAS account
Safe location in a modern environment
What you'll need:
Your skill set includes experience in troubleshooting AC and DC electrical systems, as well as experience with motion control, conveyors, motors, pneumatics, sensors, and with PLC's (Allen Bradley controllers / Epson and Fanuc Robots experience is a plus)
You can disassemble and re-assemble and troubleshoot complex mechanical systems
You have 5+ years of experience working in a technical/Industrial Manufacturing Maintenance and repair capacity
You'll be able to work overtime and/or on the weekends, if there is a business need.
What you'll do:
You will perform preventative and corrective maintenance on all manufacturing equipment, managed through a computerized maintenance management system (CMMS)
You will troubleshoot and repair complex electro-mechanical systems including vision guided robots, motors, pneumatic pick and place, precision liquid dispensing, ultrasonic welding, and cam / indexer driven equipment
When working to solve problems you will use root cause analysis, and recommend corrective action and you will analyze and compile engineering data to draw conclusions
Your day-to-day activities will include working with engineering and production support to ensure the safe, efficient, and productive operation of the manufacturing equipment
Why IDEXX?
We're proud of the work we do, because our work matters. An innovation leader in every industry we serve, we follow our Purpose and Guiding Principles to help pet owners worldwide keep their companion animals healthy and happy, to ensure safe drinking water for billions, and to help farmers protect livestock and poultry from disease. We have customers in over 175 countries and a global workforce of over 10,000 talented people.
So, what does that mean for you? We enrich the livelihoods of our employees with a positive and respectful work culture that embraces challenges and encourages learning and discovery. At IDEXX, you will be supported by competitive compensation, incentives, and benefits while enjoying purposeful work that drives improvement.
Let's pursue what matters together.
IDEXX values a diverse workforce and workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
IDEXX is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited by local, state, or federal laws.
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Auto-ApplyBioProcess Engineer
Racine, WI jobs
About Us Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. A Brief Overview
Contributes to equipment projects and manufacturing process improvements. Provides insight and contributes to production reliability. Participates as a team member for technical operations sections of product development projects, including scale-up and production line design. Leads process development and equipment projects while maintaining schedules and meeting budgets. Success is measured through implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals. What You Will Do
Process design Coordinates implementation of manufacturing equipment, process automation, process expansions, and new initiatives. Includes project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
Process sustenance Identify production interruptions and establish risk mitigations. Troubleshoot equipment and processing issues in support of production goals. Determine calibration and maintenance needs of new equipment.
Process evaluation Establish new product costs, develop and implement necessary SOP's, and establish processing, packaging and test specifications for products and equipment. Identify process inefficiencies and implement strategies, including automation and scale-up, to identified areas.
Maintain Budgets Create and maintain project time lines and plans, accelerating where possible. Create project and/or capital budgets in cooperation with management to meet department budgets.
Minimum Requirements
Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science.
Less than 1 year of relevant work experience.
Preferred Qualifications
Master of Science (M.S. or M.Sc.) in Engineering, Business, or related discipline.
3+ years of medical device or pharmaceutical process experience or similar experience in a regulated industry.
Technical & Functional Skills
Familiar with ISO 13485 / FDA QSR / GMP / Other medical industry regulations.
Ability to formulate program strategy, budgets and timelines.
Solidworks and/or AutoCAD.
Six Sigma Methodologies.
Statistical Analysis.
Strong technical and problem-solving skills.
Ability to communicate and write effectively.
Benefits:
Comprehensive Medical, Dental, and Vision plans
20 days of Paid Time Off
15 paid holidays
Paid Sick Leave
Paid Parental Leave
401(k)
Employee bonuses
And more!
Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.