Stellenbeschreibung

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions.

CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.

Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor.

CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

We are committed to creating a diverse and inclusive workplace environment. An environment where colleagues can fulfill their career aspirations, realize their potential, and use their unique perspectives and experiences to make a difference in a world that needs solutions to rare and serious disease.

The Role

Could you be our next Manager of Cell Manufacturing? This is a hybrid opportunity at our Pasadena CA location.

You will manage cGMP compliant Cell Manufacturing operations meeting planned production outputs, oversee manufacturing campaigns and staff, work in collaboration with Quality, Engineering, Maintenance and Supply Chain. You

will report to the Director of Gene Therapy Cellular Manufacturing and have Scientist and Associate Scientist report to you.

Your skills and experience

• Manage manufacturing operations of a cGMP-compliant Cell Manufacturing facility to meet planned production targets with allocated resources.
• Produce SOPs, MBRs, and EOPs for equipment and procedures used in routine GMP Cell Manufacture
• Provide technical expertise and leadership for the Cell Manufacturing Facility, including Equipment Selection, facility procedures, reports, risk assessment and material ordering.
• Review validation documents to support manufacturing processes.
• Ensure deviations, CAPA, change controls, process transfers, and other goals are supported to completion.
• Support internal and external technology transfers and engage CMOs.
• Prepare data packages for regulatory agencies, internal and external presentations and publications.
• Manage manufacturing resources, production schedules and budget. Hire and develop manufacturing Scientists and Associates.
• Develop training material, update curricula and support ongoing training of manufacturing staff.
• Critically analyze manufacturing data. Prepare reports and present results to management and other team members.

REQUIREMENTS

• Masters in Biotechnology, Biomedical Engineering, Molecular Biology or other related field required or experience in relevant discipline.
• Minimum of 3 years' relevant industry experience or equivalent experience in a relevant academic environment.
• Experience working in a GMP biologics manufacturing environment, for Cellular and Gene Therapy products.
• Experience in Training and managing staff.

The expected base salary range for this position at hiring is $110,000 - $150,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting.

Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors.

In addition to base salary, total compensation for this role may also include incentive compensation and equity.

LI-HYBRID

About Us

Our Benefits

We encourage you to make your well-being a priority. Its important and so are you. Learn more about at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.

Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!

Education

• Engineering Degree, Manufacturing Duties / Responsibilities The Process Engineer provides key technical support to manufacturing through;
• Using engineering methods to investigate, analyze and upgrade manufacturing processes, methods, technology, and / or equipment in order to maximize production efficiencies, reduce costs and improve product quality.
• Development and deployment of technology that supports improved processes understanding and product innovation.
• Optimization of process controls with consideration of value contribution.
• Supporting continuous improvement initiatives such that they become entrenched in the company’s culture and operations.
• RESPONSIBILITIES : Partnering with internal customers to improve production processes & process knowledge of operators.
• Utilization of SPC and advanced problem solving tools and the delivery of education and competency to colleagues.
• Standardization of work.
• Managing resources appropriately to develop specialized knowledge that impacts product quality and efficiency.
• Design and implementation of adopted cost savings suggestions relative to processing and / or plant equipment.
• Work collaboratively with internal customers, engineering, commercial teams on new product development projects and their implementation within operations.

This could include the commissioning of capital assets in conjunction with Project Leaders and others.

• Liaise with all parties to co-ordinate project scheduling and execution.
• Actively participate and support all safety initiatives within the manufacturing location.
• REQUIRED SKILLS AND ABILITIES : Degree in Engineering relatable to Manufacturing.
• Solid knowledge of statistical process control and its application, project management, time management and computer programming tools (Solidworks, Auto CAD, Excel, Word, Minitab, ERP).
• Experience with Continuous Improvement.
• Other skills required : teamwork, collaboration, planning, organizing, customer service orientation, analysis, problem assessment, problem solving, innovation, and creativity.

Description

Overview

Teledyne API (TAPI), a business unit within the Environmental and Electronic Measurement Instruments group within Teledyne Technologies Incorporated (NYSE : TDY), continues to be the global leader in the manufacturing of advanced instrumentation for monitoring of atmospheric pollution.

We design, manufacture and market precision gas analyzers and air quality monitoring products both domestically and internationally.

Teledyne is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, gender, sexual orientation, gender identity, gender expression, transgender, pregnancy, marital status, national origin, ancestry, citizenship status, age, disability, protected Veteran Status, genetics or any other characteristic protected by applicable federal, state, or local law.

JOB SUMMARY

This position reports to the Technical Support Supervisor and plays a key role in the assistance of the Technical Support and Production Departments.

This position will also interface with customers to provide assistance and technical troubleshooting of SO2, TRS, H2S, NOX, NO, NO2, NH3, O2, O3, CO, CO2, N2O gas instrumentation, and PM10, PM2.

5 particulate instrumentation. This position will begin within the Customer Service / Repair Lab as part of the training progression towards potentially an Engineering Technician role within the Technical Support Center.

ESSENTIAL JOB DUTIES

• Will provide customer assistance by repairing, advising on the repair and use, and factory repair of API analyzers and associated equipment used in their operation.
• Works on assignments that are semi-routine in nature but recognizes the need for occasionally deviation from accepted practice.
• Electronic troubleshooting and resolving problems in both software-controlled Analog and Digital surface mount circuit boards.
• Responsible for solving start-up and calibration problems and repairing instruments for the assigned products.

QUALIFICATIONS

• Associates degree in a mechanical related field or equivalent work experience with air pollution instrumentation and / or other mechanical / electro-mechanical machinery.
• 3-5 years of experience and / or education in a service-related environment, particularly oriented toward electronic, pneumatic and electromechanical instrumentation.
• Must have experience using the following test equipment : VOM, oscilloscopes, recorders, hand tools, test jibs and custom test equipment as required.
• Must be able to exercises judgment within defined procedures and practices to determine appropriate action.
• Must be able to communicate and articulate professionally and clearly both verbally and in writing.
• Must possess problem solving skills, strong digital and analog skills, and the ability to troubleshoot in a logical manner with high attention to detail.
• Requires general computer skills and knowledge of Word, Excel and Power Point programs.
• Excellent interpersonal skills required for customer and team interaction -Environmental Industry product knowledge, a plus.
• Experience with Microsoft AX and Salesforce a plus.

PHYSICAL REQUIREMENTS

• This position will require travel within and outside of the United States 10% of the time.
• This position will involve repetitive work utilizing hand tools, a computer, keyboard, and mouse 75% of the time.
• The position will require frequent sitting, reaching, twisting, turning, standing, stooping, bending, pushing, pulling, walking, turning, and twisting.

California Pay Transparency Statement

Please note the salary range posted below is a general guideline for this job level and location. When extending an offer, a variety of factors are considered such as responsibilities of the position, relevant education and experience, certifications, knowledge and skills.

Salary Range :

$41,800.00 - $69,850.00

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders.

Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws.

ABOUT Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech.

We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests.

Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.

Our work at Truvian is more than a job It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to putting health information where it belongs - in the hands of the individual.

We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers! JOB SUMMARY We are seeking a talented and experienced Manufacturing Engineer 3 or Senior Manufacturing Engineer to join the Manufacturing Engineering team.

Candidates demonstrating increasing responsibility and direct experience in diagnostic consumables manufacturing within the life sciences industry will be considered.

The scope of the role includes but is not limited to, the hands-on design, modification, characterization, and ultimate qualification of production processing equipment and sustaining supporting processes in manufacturing diagnostics consumables.

These consumables include an injection molded disc, reagent cartridge, and a microfluidic sub-system component, some of the consumables utilized within Truvian’s platform.

The individual filling this role will work closely with consumable design engineers, automation design engineers, quality, technicians and operators, and other members of the broad organization.

The candidate needs strong communication skills to present concepts, experiments, and results to management and top leadership Since equipment qualification, process characterization, process optimization, and process validation are principal responsibilities of this position, strong attention to detail and clear and concise documentation protocol preparation and execution are required.

HERE’S WHY YOU’LL LOVE THIS JOB : You will be integral in launching the first core product for Truvian, which is a game changer! You'll work with a rock-star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products.

You’ll be a key player on a team responsible for the company’s growth and product launch. You thrive in a fast-paced and dynamic environment where you can implement fresh ideas, and new processes, and make things happen quickly without a bunch of red tapes.

You’ll have great perks such as Generous Benefits (Medical / Dental / Vision / EAP / Paid Life Insurance / LTD / 401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on-site gym, and virtual classes, and a farm to table on-site restaurant including a 30% discount.

WHAT YOU WILL DO On-site role is responsible for constructing, executing, and evaluating controlled experiments (including DOE's) to optimize processes, address yield, and quality issues, and drive implementation of solutions into a production environment.

Analyze existing processes and identify areas for improvement, proposing and implementing solutions to enhance efficiency, reduce waste, and increase throughput.

Design and implement process control systems to monitor and optimize production parameters, ensuring consistent product quality and compliance with safety and regulatory standards.

Independently create and execute Equipment Qualification (IQ / OQ / PQ) and Process Validation (PV) protocols to qualify manufacturing processes.

Provide technical expertise and support to production teams, troubleshooting process-related problems, and implementing corrective actions.

Assist the manufacturing engineering team in developing, building, testing, and qualifying equipment as required. Communicate results and challenges with colleagues.

Interact with technical users of IVD systems to understand issues they observe. Lead or contribute to continuous improvement initiatives, such as Lean Manufacturing or Six Sigma projects, to drive operational excellence and optimize overall manufacturing performance.

WHAT YOU WILL BRING : Applicants should possess a Bachelor's degree, preferably in Life Sciences or Engineering, and a minimum of five years of industry experience in operations engineering.

Ideally, candidates would have exposure to life sciences, diagnostics, and / or medical devices gained from working in both small and large companies.

The ideal candidate will have extensive experience in : Achieving impossible timelines through a combination of superior planning, proven assessment of risk, and the ability to inspire and enable others to move fast.

Partnership and collaboration, ensuring relationships are at the forefront of our strategy, emphasizing the company and team over personal goals.

Demonstrate effective communication skills, both orally and in writing, by consistently and clearly conveying information to internal and external stakeholders.

Maintain timely communication to ensure alignment among all parties involved, enabling the delivery of impactful outcomes with efficiency.

Proficient in utilizing a wide range of tools, including experience in implementing and working with ERPs, Microsoft Office suite, and other essential software.

Proficient in problem-solving and equipped with powerful analytical skills, enabling proactive identification and resolution of issues.

Possesses a solution-oriented mindset and exceptional time management abilities. Self-motivated personality, capable of self-instruction and quality completion of projects with tight deadlines and under intermittent supervision.

Ability to quickly grasp complex technical, procedural, and regulatory concepts and apply them to assignments. Excellent verbal and written communication skills, including presentations to peers, leaders, and executives.

Previous experience in maintenance, preferably in medical devices or IVD product development, is strongly preferred. Direct experience in a GMP / ISO 13485-regulated manufacturing environment is highly desired.

Direct experience with Equipment Qualification (IQ / OQ / PQ) in an FDA Class II / III industry is highly desired. SUPERVISORY ROLE No SALARY RANGE $90,500 to $109,000 Manufacturing Engineer 3 $110,000 to 130,000 Sr.

Manufacturing Engineer This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to, experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.

Salary offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.

PHYSICAL DEMANDS AND ABILITIES Regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear Ability to lift and move over 25 lbs.

repeatedly and safely, occasionally 75 lbs. with assistance Frequently required to stand, walk, stoop, kneel, crouch, or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus If you want to stand out, please include a cover letter Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Powered by JazzHR

Job Summary

General Atomics (GA), and its affiliated companies, is one of the world’s leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted aircraft, airborne sensors, and advanced electric, electronic, wireless and laser technologies.

This manufacturing engineer is responsible for overseeing and improving manufacturing, assembly and testing for high power RF components and systems.

The position develops schedules and implements work activities for the manufacturing, assembly and testing of high power RF components and systems.

Coordinates day to day activities of the manufacturing process, including personnel guidance, work assignments, procurement and coordination of the product flow through the manufacturing phase.

Generates and executes policies and procedures and recommends modifications to operating policies.

DUTIES & RESPONSIBILITES

• Attends to day-to-day activities, generating technical documents, maintaining project schedules, and working closely with others on the technical team.
• Generates process flows, procedures, and interfaces with quality assurance personnel.
• Gives guidance to assemblers and technicians, through all phases of manufacturing in accordance with established schedules.

Schedules and coordinates work assignments.

• Interacts with vendors to ensure timely delivery of material and sub-components.
• Supports the fabrication, modification, installation, and documentation of complex laboratory, experimental or commercial equipment.
• Works with design engineers to resolve design and documentation issues.
• Seeks methods to maintain and improve product quality, repeatability and efficiency.
• Expected to work in a safe manner in accordance with established operating procedures and practices.
• Performs other duties as assigned or required.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.

Job Qualifications

Typically requires a bachelors degree, masters degree or PhD in engineering or a related technical discipline from an accredited institution and progressive engineering experience as follows;

six or more years of experience with a bachelors degree, four or more years of experience with a masters degree, or two or more years with a PhD.

May substitute equivalent engineering experience in lieu of education.

• Must demonstrate technical understanding of manufacturing, assembly and test concepts and practices, with the ability to schedule and coordinate workloads to meet established milestones.
• Must be customer focused and possess :
• The ability to identify issues, analyze and interpret data and develop innovative solutions to a variety of complex matters of diverse scope and nature;
• Excellent analytical, verbal and written communication skills to accurately document, report, and present findings to a variety of audiences including management;
• Excellent interpersonal skills to influence and guide all levels of employees;
• The ability to maintain the confidentiality of sensitive information;
• The ability to represent the company on external projects; and
• The ability to handle common computer tasks.
• Preferred but not required, knowledge of microwave systems, RF test equipment, vacuum systems, and / or complex machinery is a plus.