Manufacturing Engineer jobs at Johnson & Johnson

- 918 jobs

Staff Quality Engineer
Johnson & Johnson 4.7
Manufacturing engineer job at Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. Position Summary: This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis and provides input or approval for detailed design specifications, tooling, fabrication, and testing. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc. Staff Quality Engineer Duties Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development. Researches and compiles worldwide regulatory and technical standards for shift in design related quality trends. Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization. Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems. Oversees the implementation of world with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. Provides support to Johnson and Johnson process excellence initiatives including six sigma, design excellence, and lean thinking. Oversees engineering operations, scientific evaluations of new products, technology concepts and development. Purchases or designs equipment that meets health, safety and environmental standards set by the company. Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes. Assures compliance with all local government and company regulations, policies and procedures. Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests. Researches and reports on competitors' design strengths and weaknesses. Provides technical expertise across a broad range of engineering areas and methodologies. Leads and oversees the activities of engineers and support staff. Responsible for communicating business related issues or opportunities to next management level. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed. May support technical training (i.e. statistics and quality methods) and teaching/mentoring of other Required Experience and Skills: A minimum of 6 years of work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience Advanced knowledge of Quality Engineering/Scientific methods and techniques Applied statistics of growing complexity Test method development, statistics, and reliability Experience working within a team, acquiring feedback, negotiating, and training Understand new concepts quickly, research and maintain ongoing learning of industry regulations Fundamental technical understanding of manufacturing equipment and processes Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) Preferred Experience & Skills: Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications An ASQ certification (CQE, CQM, CRE or CQA) Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) Other: This position is located in Cincinnati, OH and has up to 10% of both domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $91,000-$147,200 USD$ Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
$91k-147.2k yearly Auto-Apply 19d ago
Manufacturing Test Automation Engineer (Python)
Red Oak Technologies 4.0
San Francisco, CA jobs
Manufacturing Test Engineering Manager (or Senior/Lead Test Engineer) Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily. This role is fully onsite in San Francisco, CA. Position Overview The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis. The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing. Key Responsibilities Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing. Serve as a working manager, providing technical leadership while contributing hands-on daily. Mentor and train Test Engineers on both technical and soft skills. Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives. Collaborate with cross-functional teams on software development, verification, and validation for new product introductions. Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization. Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation. Communicate project updates, risks, and recommendations to management and stakeholders. Ensure timely completion of team deliverables and proactively address constraints or delays. Support contract manufacturing facilities with occasional travel (less than 10%). Work full-time onsite in San Francisco, CA. Qualifications and Skills Strong proficiency in Python development (minimum 5 years). Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design. Strong skills in debugging, programming, data collection, and data analysis. Experience using project tracking tools such as Jira, Confluence, or equivalents. Proven ability to deliver results in a fast-paced engineering environment. Excellent organizational skills with the ability to manage multiple concurrent projects. Demonstrated people management or technical leadership experience (3+ years preferred). Experience working with high-precision electro-mechanical assemblies. Preferred: Experience developing test software for high-volume production and test equipment. Education BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required. MS degree preferred. Additional Information Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses. This position is within an electrical component manufacturing environment (not medical devices). About Red Oak Technologies Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences. Red Oak Core Values: Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone
$98k-140k yearly est. 4d ago
Quality Engineer
Alexander Technology Group 4.3
Portsmouth, NH jobs
Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area. This is full-time (perm) On-site in Portsmouth, NH Key Responsibilities: Develop and maintain quality systems for combination products. Ensure compliance with FDA, ISO 13485, cGMP, and other standards. Lead risk assessments, root cause analyses, and corrective actions. Oversee testing, validation, and documentation processes. Collaborate with R&D, manufacturing, and regulatory teams. Conduct training on QA practices and support continuous improvement. Perform inspections and product testing to ensure quality standards. Qualifications: Bachelor's in Engineering, Life Sciences, or related field. Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA). Excellent problem-solving and communication skills. Able to work independently in a small team environment. Preferred: Experience with design control, eQMS, and statistical tools. ASQ CQE certification. 3+ years in QA/QE roles with combination products. If interested, please send resume to ************************
$71k-96k yearly est. 5d ago
Engineer I, Commercial Manufacturing
Xeris Pharmaceuticals 4.2
Chicago, IL jobs
Support all functions of the pharmaceutical supply chain for all commercial products. Ensure product is manufactured in a quality manner under cGMP's and available for sale based on commercial forecasts. Ensure inventory and supplies are available at every point within the supply chain to meet production schedule. The Engineer I will provide a broad understanding of the manufacturing supply chain from drug substance manufacturing through commercial packaging and working within a matrixed organization. The Engineer I / II will assist with planning and execution of routine technical assignments and demonstrates firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing. Responsibilities Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to: Assist in commercial production planning Support colleagues in the day-to-day manufacturing activities on a routine basis to ensure commercial supply Helps with logistics activities such as quotes, invoices, inventory management and shipment of products and intermediates Frequently interacts with other functional peer group managers and CMOs to support the commercial manufacturing or development activities Accurately collects / performs data mining and appropriately records / trends observations Aid in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations Collaborate with other functions such as Device Development, Quality Assurance, Quality Control, Regulatory, and Finance Qualifications Bachelor's degree required, master's degree preferred in Engineering or relevant Supply Chain, Scientific, or equivalent degree with 3 to 5 years of experience working in pharmaceuticals Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with sterile drug product manufacturing Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management Skills preferred: Data Management, Manufacturing/Supply Chain background Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel may be required up to 20% at times to CMOs and CSPs location. Periodic overnight travel may occur for work. This position is based in Xeris' Chicago office. A minimum of four days per week on site is required. On site requirement may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $80,000 to $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
$80k-110k yearly Auto-Apply 13d ago
Process Development Associate II
AGC Biologics 3.6
Bothell, WA jobs
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Process Development Associate II to join our Analytical and Formulation Development (AFD) team. AFD develops robust analytical methods to support drug release testing, upstream and downstream development, and non-GMP studies. The team also provides molecular characterization and scientific expertise for deviation investigations. In this role, you'll focus on executing analytical methods - primarily HPLC/UHPLC and capillary electrophoresis (CE-SDS, ic IEF)-to support process development activities. You'll work closely with experienced scientists, contribute to method optimization, and help drive continuous improvement projects within the department. This position is a great fit for someone who enjoys hands-on lab work, collaborating with teammates, and learning in a supportive environment. Location: Bothell, WA Schedule: Monday through Friday, onsite Compensation Range: $66,960 - $92,070 Essential Job Duties / Responsibilities Perform analytical testing in support of process development following established protocols. Assist in the development and optimization of analytical methods. Support method transfer to Quality Control. Coordinate and perform instrument maintenance and troubleshooting. Ensure accurate and complete documentation of results. Author, review, and edit analytical protocols and reports. Contribute to laboratory operations and continuous improvement efforts. Leadership Skills Communicates clearly and effectively with colleagues and customers. Solves straightforward problems and explains logic and decisions to others. Collaborates with teammates to support project and department goals. Qualifications BS/BA degree in biochemistry, protein chemistry, or related field, plus 2+ years of experience in an analytical lab. Required: Experience in chromatography (HPLC/UHPLC), preferably across multiple modes (SEC, IEX, RP, affinity). Preferred: Experience with capillary electrophoresis (CE-SDS, ic IEF). Strong interpersonal and teamwork skills; able to thrive in a fast-paced environment. Ability to adapt quickly to changing priorities or technical challenges. Strong data management skills and attention to detail in documentation and execution. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit *************** W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
$67k-92.1k yearly Auto-Apply 58d ago
Supervisor Manufacturing
Frontage Laboratories 3.9
Exton, PA jobs
Job Description Manufacturing Manager Title: Manager, Manufacturing Operations Reports to: Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed. Roles & Responsibilities: Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing. Manage a team of manufacturing technologists, operators, and warehouse coordinators. Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution. Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required. Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs. Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM. Write, review and approve SOP's, qualification protocols, and other GMP documentation. Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients. Implements site initiatives in production operation as advised by site management. Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications. Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports. Responsible for compliance monitoring of area operations. Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues. Process and analyze manufacturing results, data and provide status updates to the management. Establish and maintain positive relationships with project stakeholders. Education, Experience & Skills Required: Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry. Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing. 5+ years of people management experience. Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations. Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable. Ability to perform frequent physical tasks with strength and mobility. Experience in microbiology and sterile manufacturing is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$60k-85k yearly est. 1d ago
Supervisor Manufacturing
Frontage Laboratories 3.9
Exton, PA jobs
Manufacturing Manager Title: Manager, Manufacturing Operations Reports to: Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed. Roles & Responsibilities: Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing. Manage a team of manufacturing technologists, operators, and warehouse coordinators. Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution. Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required. Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs. Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM. Write, review and approve SOP's, qualification protocols, and other GMP documentation. Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients. Implements site initiatives in production operation as advised by site management. Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications. Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports. Responsible for compliance monitoring of area operations. Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues. Process and analyze manufacturing results, data and provide status updates to the management. Establish and maintain positive relationships with project stakeholders. Education, Experience & Skills Required: Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry. Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing. 5+ years of people management experience. Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations. Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable. Ability to perform frequent physical tasks with strength and mobility. Experience in microbiology and sterile manufacturing is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$60k-85k yearly est. Auto-Apply 60d+ ago
Process Development, Associate Director - Cell Line Development (CLD), Biologics
Vertex Pharmaceuticals, Inc. 4.6
Boston, MA jobs
Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics. The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making. Key Duties and Responsibilities: * Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities. * Evaluate, select and manage external capabilities for cell line development. * Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies. * Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation. * Develop and manage project timelines and budget for CLD activites. * Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals. * Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer. * Review and approve technical protocols, development reports, and data packages provided by CDMOs. * Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners. * Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD. * Serve as a subject matter expert in regulatory agency interactions, audits, and inspections. * Expected travel: 10-20% (domestic and international) Required Education: * PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience. * Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered. Required Experience and Skills: * Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins. * Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred. * Knowledge of upstream process development and analytical methods related to CLD. * Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows. * Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.). * Proven track record of delivering on complex biologics development programs. * Excellent interpersonal, communication, and organizational skills. * Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment. #LI-LE1 Pay Range: $166,800 - $250,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
$73k-88k yearly est. Auto-Apply 42d ago
Manufacturing Engineering Technician
Precision Optics Corporation 3.9
Gardner, MA jobs
Full-time Description Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data. Principal Responsibilities Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products. Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions. Assemble fragile and sensitive electro-mechanical and optical medical devices. Train manufacturing staff on assembly methods/procedures. Conduct experiments and record data in a laboratory environment; perform data analysis. Collaborate directly with engineers, production operators, quality inspectors and management personnel. Communicate technical issues clearly and effectively to engineering staff. Establish and maintain stability of late-stage development programs and build activity. Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.). Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements. Perform miscellaneous duties and projects as assigned and required. Requirements Training, Skills, Knowledge and/or Experience 3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products. Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools. General understanding of data collection, data reduction, and statistics. Experience working in FDA QSR and ISO 13485 environments preferred. Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel. Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems. Education Requirements High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required.
$51k-67k yearly est. 60d+ ago
Manufacturing Engineering Technician
Precision Optics Corporation Inc. 3.9
Gardner, MA jobs
Job DescriptionDescription: Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data. Principal Responsibilities Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products. Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions. Assemble fragile and sensitive electro-mechanical and optical medical devices. Train manufacturing staff on assembly methods/procedures. Conduct experiments and record data in a laboratory environment; perform data analysis. Collaborate directly with engineers, production operators, quality inspectors and management personnel. Communicate technical issues clearly and effectively to engineering staff. Establish and maintain stability of late-stage development programs and build activity. Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.). Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements. Perform miscellaneous duties and projects as assigned and required. Requirements: Training, Skills, Knowledge and/or Experience 3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products. Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools. General understanding of data collection, data reduction, and statistics. Experience working in FDA QSR and ISO 13485 environments preferred. Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel. Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems. Education Requirements High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required.
$51k-67k yearly est. 17d ago
Manufacturing Supervisor 2nd Shift
Capsugel Holdings Us 4.6
Tampa, FL jobs
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lead Operator, GMP Manufacturing is responsible for direct oversight of staff operations on behalf of the Shift Supervisor of all GMP clinical manufacturing, GMP commercial manufacturing and packaging operations assigned. Lead Operator is responsible for ensuring that all projects assigned are executed in a compliant and efficient manner. Lead Operator is responsible for leading the personnel assigned to their unit. They are intimately involved with the technical aspects of all assigned projects per direct supervision and ensure that their unit works across the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Lonza. Key Accountabilities: Able to perform all tasks associated with Operators l, ll and lll. Help organize workflow for assigned unit and delegate tasks to team members. Communicate with direct supervision regarding goals, targets, deadlines and plans accordingly to accomplish tasks and bring projects to completion. Lead, train and advise personnel as applicable. Represent Management as “Designee” for process-related signatory duties. Peer review executed batch records for completeness and clarity. Perform and or assign equipment set-up and daily checks to support the manufacturing operation. Interact with client representatives as necessary to address project needs. Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required. Participate in and recommend staff hiring. Provide recommendations for staff changes and improvement. Execute batch record instructions and oversight of team execution (including but not limited to: dispensing, operating equipment, testing, inspection, packaging as required, general support of the manufacturing operation in any capacity.) Work cross-functionally with supervision, QAU, PM, Technical Services (Mfg. Technical Specialists, Purchaser, Planner, Equipment & Instrumentation Engineer, Process Engineer, Validation Engineer), PDS, EHS, WH, etc. to achieve goals of the team and organization. Key Requirements: A high school diploma required. A minimum of 5 years of experience as a leader or in a management position is required. Pharma cGMP Experience is required. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
$50k-68k yearly est. Auto-Apply 3d ago
Manufacturing Engineering Technician
The Panther Group 3.9
Westborough, MA jobs
The Panther Group has an immediate need for Manufacturing Engineering Technician. The Manufacturing Engineering Technician is responsible for assisting Manufacturing Engineers in transitioning products from internal and external sources into manufacturing and supporting those products once in routine production under the direction of Manufacturing Engineers. Duties and Responsibilities Assist in maintaining and processing changes through an Engineering Change Order (ECO) process for manufacturing files and databases, including Bills of Material, manufacturing assembly and test procedures work instructions, and test records. With guidance and supervision, provide hands-on troubleshooting and problem solving support within manufacturing as needed. Make recommendations to Manufacturing Engineering to minimize downtime and improve operational processes. Collect and track identified information to support Manufacturing Engineering activities including product build and test cycle times, cost reductions and quality improvements. Assist Manufacturing Engineers with revisions and improvements to manufacturing methods and procedures, including preparing ECOs and deviations. Assist with hands on training of manufacturing employees on new products, tooling, equipment and process changes/revisions. Schedule, complete and document routine maintenance on applicable manufacturing build fixtures and test equipment. With guidance and supervision, participate in building and utilizing assembly and test equipment, including collection of data for analysis with Manufacturing Engineer. Support Lean Manufacturing and Continuous Improvement activities as directed. Assist in installation and validation of equipment and processes in the production area as directed. Comply with policies, guidelines and regulatory requirements per CT's Quality System. Qualifications Solid verbal and written skills. Strong problem solving skills. High school diploma minimum - trade school experience in technology discipline a plus. Minimum 2 years of experience in a similar/related role within a production environment. Follow Manufacturing Engineers direction. Cooperative and positive attitude. Basic computer literacy and working knowledge of MS Office tools. Experience with MRP/ERP systems a significant plus. Ability to interpret a bill of material, wiring schematic, assembly drawings desired. Working knowledge in the use of basic hand tools, screw drivers, torque wrenches, etc. Working Environment Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting. Occasional travel. Pay Rate: $24 to $29 Depending on Experience #INDENG
$24-29 hourly 27d ago
IT Manufacturing Engineer
Elanco 4.9
Indianapolis, IN jobs
At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: As a IT Manufacturing Engineer at Elanco, you will be a key technical contributor to the digital heart of our production facilities. You will specialize in implementing and supporting our Manufacturing Execution Systems (MES) and Laboratory Execution Systems (LES). This hands-on role is the critical bridge between our physical manufacturing processes and the digital systems that control and document them, ensuring our operations are efficient, compliant, and reliable. This includes four strategic priorities: Pipeline Acceleration: Optimize the search and approval of high impact medicines with a focus on speed, cost and precision. Manufacturing Excellence: Improve the efficiency, quality and consistency of core manufacturing processes, specifically execution and equipment effectiveness. Sales Effectiveness: Simplify the process to find, trust and consume relevant customer insights that drive sales growth and improved engagement. Productivity: Expand operating margin through efficiency by systematically reducing our operating expenses across the company, improving profitability. Your Responsibilities: System Design and Configuration: Contribute to the design and be responsible for the configuration and implementation of MES/LES solutions. This includes building and modifying electronic batch records (EBRs), system workflows, and configuring equipment integration based on defined requirements. Process Optimization: Collaborate with operations and quality teams to analyze manufacturing and laboratory workflows. You will use MES/LES capabilities to help implement process improvements, reduce production cycle times, and enhance data integrity at the shop-floor level. System Management and Support: Provide frontline technical support for MES and LES platforms. You will act as a key technical resource to troubleshoot and resolve system issues, ensuring high availability for our manufacturing and lab teams. Integration: Assist with the integration between MES/LES and other critical systems, such as our ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data. Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) for MES/LES enhancements and new implementations. You will be responsible for generating validation documentation and ensuring systems are maintained in a validated state, compliant with GxP and data integrity requirements. Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities. User Training and Enablement: Develop training materials and conduct training sessions to ensure that manufacturing and lab personnel are proficient in using the MES/LES systems effectively in their day-to-day roles. What You Need to Succeed (Minimum Qualifications): Educational Background: A Bachelor's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field. Required Experience: 3+ years hands-on experience with the configuration, and support of an MES or LES platform (e.g., Werum PAS-X, Emerson Syncade, POMSnet). Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry. Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles. Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and how they integrate with higher-level manufacturing systems. Database and SQL Skills: Experience with SQL for data queries to support troubleshooting, data extraction, and report generation. What Will Give You the Competitive Edge (Preferred Qualifications): Problem-Solving: Strong analytical and troubleshooting skills, with the ability to systematically diagnose and resolve technical issues. Process Analysis: A solid understanding of business process analysis and workflow design. Ability to read and interpret process maps and requirements documents. Cross-Functional Collaboration: Good communication and interpersonal skills, with a proven ability to work effectively in a team environment with operators, scientists, and management. Cloud Platform Proficiency: Familiarity with Public Cloud platforms, specifically Microsoft Azure or Google Cloud Platform (GCP), is a plus. DevSecOps: Familiarity with the concepts of DevSecOps, including Continuous Integration/Continuous Delivery (CI/CD) and source control (Git), is desirable. Communication Skills: Good verbal and written communication skills, with the ability to collaborate effectively within a technical team. Additional Information: Location: Global Headquarters- Indianapolis, IN (Hybrid environment) Travel: Minimal Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
$50k-62k yearly est. Auto-Apply 60d+ ago
Downstream Manufacturing Supervisor (Nights - A Shift)
Capsugel Holdings Us 4.6
Portsmouth, NH jobs
Manufacturing Supervisor - Downstream Lead a dedicated team on the Night Shift (7 PM - 7 AM) supporting our high-capacity 6K Bioreactor suite, overseeing critical downstream purification processes to ensure the reliable delivery of life-changing medicines. Schedule: Shift: Rotational Day Shift (7:00 AM - 7:00 PM) Pattern: 2 on, 2 off, 3 on, 2 off, 2 on, 3 off (repeating cycle) Night and Weekend shifts include additional pay. See what a role at Lonza (Portsmouth, NH) looks like-watch this short video! What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance, as well as PTO and more Our full list of global benefits can be found here: *************************************** What you will do: Supervise a group of 6-8 Manufacturing Associates, ensuring strict adherence to the production schedule and maintaining a cGMP-compliant environment at all times. Lead performance management and personnel development, fostering a culture of growth and accountability within your shift. Oversee downstream GMP operations, including equipment operation, process monitoring, and both large and small-scale buffer preparations. Maintain seamless communication with Upstream and Downstream suites to synchronize activities and prevent schedule disruptions. Review electronic documents and logbooks in accordance with Good Documentation Practices (GDPs) to ensure data integrity. Manage individual training plans for all direct reports, ensuring the shift remains fully qualified to execute all scheduled operations. Ensure the facility and equipment remain in audit-ready status through rigorous adherence to 6S programs and facility standards. What we are looking for: Education: High School Diploma or Equivalent is required; an Associate's or Bachelor's degree in a Science-related discipline is preferred. Experience: Some prior supervisory or leadership exposure Leadership Qualities: Proven ability to make logical decisions and apply critical thinking skills in a fast-paced production environment. Communication: Strong written and verbal communication skills are essential for coordinating across shifts and departments. Cultural Alignment: Ability to live our cultural beliefs with the flexibility to adapt to changing business priorities. Growth Mindset: A professional who actively seeks out performance feedback and translates it into tangible improvements for themselves and their team. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.
$74k-106k yearly est. Auto-Apply 2d ago
Manufacturing Supervisor (Nights) - Cell Therapy
Capsugel Holdings Us 4.6
Portsmouth, NH jobs
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their idea, big and small, genuinely improve the world, and that's the kind of work we want to be a part of. The Manufacturing Technical Supervisor will provide a safe, controlled work environment in all areas of responsibility. He or she must be aware of the site safety objectives and make sure they are communicated and understood by all staff. The Manufacturing Technical Manager will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations until the manufacturing staff is fully proficient. The Manufacturing Technical Supervisor will provide in suite oversight of the manufacturing process during critical operations (i.e. harvest, vial filling, visual inspection, etc.) Work with Internal and Joint Project Teams to bring on and maintain customers' processes in production facility. Responsible for all tech transfers from a manufacturing standpoint. The Manufacturing Technical Manager must attend the lessons learned events for the Cell Therapy (CT) area and own actions for manufacturing. Own and manage planned deviations and change controls related to start-up of Cell Therapy. Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. Collaborate with Manufacturing Supervisor(s) to incorporate process and operational improvements into new customer processes in manufacturing. Collaborate with Senior Manufacturing Manager to determine equipment and materials the suite will need to purchase in order to run the process. May be required to provide input to Head of Emerging Technology and/or Senior Manager for budgetary/financial planning. May act as fill in for Senior Manufacturing Manager in their absence. Key Responsibilities Support the definition and execution of Operational Readiness Activity for all Emerging Technology projects at Lonza Portsmouth (LPO) to include. Set up of manufacturing procedures & collaboration with Quality Assurance (QA) to develop & execute quality systems aligned with existing operations & finished dose requirements. Support building & establishing the manufacturing team. Delivery of clinical & commercial material as required. Support the development and execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, Cleaning, and Scheduling. Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements. Provide oversight and support to the definition and execution of Technical Transfer activities for Cell Therapy Projects at LPO to include operational input into material requirements, process execution & methods transfer, operational input into defining & executing manufacturing activity related to Technical Transfer - water runs, training runs, particle runs, engineering runs etc. Enable timely delivery of milestones for the Technical Transfer. Coordination with Portsmouth Mammalian Operations and customer technical team. Timely and accurate financial reporting of project progress & revenue status Progression of proposals and change orders. Appropriate interaction with key external (customer) and internal stakeholders. Perform other duties as assigned. Key Requirements Related working knowledge with degree, significant work experience without degree required BS Preferred, additional experience in lieu of degree considered Direct interaction with regulatory agencies Core involvement in Technical Transfer and project activity Leadership of organizational change, staff hiring and training Continuous Improvement activities Generation and optimization of electronic batch documentation Experience of biological manufacturing operations - Fermentation, Purification, Drug Product Filling and Freezing processes. Experience operating automated Drug Product Filling machines using Isolator technology Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred Experience of automated and manual visual inspection systems preferred. Solid staff management experience and proven ability to manage budgets. Ability to work inter-departmentally and potentially with customers. Excellent leadership skills a must. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
$74k-106k yearly est. Auto-Apply 56d ago
Manufacturing Supervisor (Night Shift)
Capsugel Holdings Us 4.6
Portsmouth, NH jobs
Posted Job Advert The actual location of this job is in Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. Project Albacore Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Join a global team of over 18,000 people making a meaningful difference from day one. As a GMP Manufacturing Supervisor at our Portsmouth site you will coordinate and support production activities for Cell and Gene processes. Find out more about what a life at Lonza in Portsmouth, NH could look like for you by watching this short video. What you'll get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. The full list of our global benefits can be also found on *************************************** What you'll do: Coordinate and support the execution of Cell and Gene production activities, ensuring compliance with ET and site quality systems. Lead and develop the manufacturing team to meet business needs and career goals. Support the timely and complete delivery of clinical and commercial materials. Coordinate various strategies, including EHS, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management and EM. Maintain manufacturing areas to the highest cleanliness and 6S standards. Support technology transfer activities and ensure timely goal achievement. Establish methods and procedures for attaining specific goals. What we're looking for: BS degree preferred significant experience may be considered in lieu of degree. Minimum 5 years related experience with a degree or 8 years without. Proven experience in biological GMP manufacturing operations. Strong leadership and team development skills. Ability to coordinate complex projects and ensure timely delivery. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
$74k-106k yearly est. Auto-Apply 7d ago
Aerospace Engineer
SST Direct 4.2
Glastonbury, CT jobs
Job DescriptionDIRECT HIRE: An amazing opportunity for an experienced Aerospace Engineer to join a dynamic team in the Manchester, CT. area. The successful candidate must have a CNC Machinist background. This isn't a desk-only role. This position bridges design and manufacturing, develops machining processes. The candidate will write and optimize CNC programs. Also work hands-on with machinists to deliver aerospace-grade precision. Salary: $120K - $130K (Based on Experience) Schedule: Monday - Friday, 8AM - 5PM (flexible) Benefits: Medical, dental, vision, 401K, PTO, holidays Role & Responsibilities: Develop and improve CNC processes for aerospace components Program, set up, and optimize multi-axis mills and lathes Support design reviews and ensure manufacturability of complex parts Collaborate with production and quality teams to meet AS9100D / NADCAP standards Lead continuous improvement for tooling, setup time, and cycle efficiency Skills & Experience: Proven CNC machining expertise - you've run the machines yourself Strong aerospace or precision manufacturing background Working knowledge of GD&T, CAD/CAM, and process documentation Ability to solve problems on the shop floor and communicate across teams Engineering degree preferred but not required - hands-on skill is a must Must possess a minimum 10 years' CNC Machinist experience Once you apply, please text "AE" to ************ for a faster reply. INDH Powered by JazzHR DmcoKd24yt
$120k-130k yearly 2d ago
Aerospace Engineer
SST Direct 4.2
Glastonbury, CT jobs
Job DescriptionDIRECT HIRE: An amazing opportunity for an experienced Aerospace Engineer to join a dynamic team in the Manchester, CT. area. The successful candidate must have a CNC Machinist background. This isn't a desk-only role. This position bridges design and manufacturing, develops machining processes. The candidate will write and optimize CNC programs. Also work hands-on with machinists to deliver aerospace-grade precision. Salary: $120K - $130K (Based on Experience) Schedule: Monday - Friday, 8AM - 5PM (flexible) Benefits: Medical, dental, vision, 401K, PTO, holidays Role & Responsibilities: Develop and improve CNC processes for aerospace components Program, set up, and optimize multi-axis mills and lathes Support design reviews and ensure manufacturability of complex parts Collaborate with production and quality teams to meet AS9100D / NADCAP standards Lead continuous improvement for tooling, setup time, and cycle efficiency Skills & Experience: Proven CNC machining expertise - you've run the machines yourself Strong aerospace or precision manufacturing background Working knowledge of GD&T, CAD/CAM, and process documentation Ability to solve problems on the shop floor and communicate across teams Engineering degree preferred but not required - hands-on skill is a must Must possess a minimum 10 years' CNC Machinist experience Once you apply, please text "AE" to ************ for a faster reply. INDH Powered by JazzHR YnNz44Qylu
$120k-130k yearly 2d ago
Aerospace Engineer
SST Direct 4.2
Springfield, MA jobs
Job DescriptionDIRECT HIRE: An amazing opportunity for an experienced Aerospace Engineer to join a dynamic team in the Manchester, CT. area. The successful candidate must have a CNC Machinist background. This isn't a desk-only role. This position bridges design and manufacturing, develops machining processes. The candidate will write and optimize CNC programs. Also work hands-on with machinists to deliver aerospace-grade precision. Salary: $120K - $130K (Based on Experience) Schedule: Monday - Friday, 8AM - 5PM (flexible) Benefits: Medical, dental, vision, 401K, PTO, holidays Role & Responsibilities: Develop and improve CNC processes for aerospace components Program, set up, and optimize multi-axis mills and lathes Support design reviews and ensure manufacturability of complex parts Collaborate with production and quality teams to meet AS9100D / NADCAP standards Lead continuous improvement for tooling, setup time, and cycle efficiency Skills & Experience: Proven CNC machining expertise - you've run the machines yourself Strong aerospace or precision manufacturing background Working knowledge of GD&T, CAD/CAM, and process documentation Ability to solve problems on the shop floor and communicate across teams Engineering degree preferred but not required - hands-on skill is a must Must possess a minimum 10 years' CNC Machinist experience Once you apply, please text "AE" to ************ for a faster reply. INDH Powered by JazzHR sf UuqXFMJT
$120k-130k yearly 2d ago
Aerospace Engineer
SST Direct 4.2
East Hartford, CT jobs
DIRECT HIRE: An amazing opportunity for an experienced Aerospace Engineer to join a dynamic team in the Manchester, CT. area. The successful candidate must have a CNC Machinist background. This isn't a desk-only role. This position bridges design and manufacturing, develops machining processes. The candidate will write and optimize CNC programs. Also work hands-on with machinists to deliver aerospace-grade precision. Salary: $120K - $130K (Based on Experience) Schedule: Monday - Friday, 8AM - 5PM (flexible) Benefits: Medical, dental, vision, 401K, PTO, holidays Role & Responsibilities: Develop and improve CNC processes for aerospace components Program, set up, and optimize multi-axis mills and lathes Support design reviews and ensure manufacturability of complex parts Collaborate with production and quality teams to meet AS9100D / NADCAP standards Lead continuous improvement for tooling, setup time, and cycle efficiency Skills & Experience: Proven CNC machining expertise - you've run the machines yourself Strong aerospace or precision manufacturing background Working knowledge of GD&T, CAD/CAM, and process documentation Ability to solve problems on the shop floor and communicate across teams Engineering degree preferred but not required - hands-on skill is a must Must possess a minimum 10 years' CNC Machinist experience Once you apply, please text "AE" to ************ for a faster reply. INDH
$120k-130k yearly Auto-Apply 17d ago