Packaging Engineer jobs at Johnson & Johnson - 540 jobs

HTI and PAI Pharma are seeking an Equipment Packaging Engineer for their facility in Greenville, SC. PAI Pharma is a leader and manufacturer of liquid medications in the United States. They've been in business for over 50 years, and they are continuously growing! The salary range for this position is starting at around $90k annually, dependent upon experience. What They Offer: Full benefits package - Medical, Dental, Vision, EAP, 401k Match Onsite Wellness Center Tuition Reimbursement 13 Paid Holidays Progressive PTO Plan What You Need: Bachelor's degree in Mechanical Engineering, Packaging Engineering, Electrical Engineering, Mechatronics, or related field. 5-10 years of experience working with packaging equipment in the pharmaceutical, biotech, food, beverage, or consumer products industry. Strong knowledge of packaging equipment design, automation, mechanical systems, controls, and integration. Experience with FAT/SAT, commissioning, and qualification (IQ/OQ/PQ). Understanding of cGMP, FDA/regulated environments, and packaging line compliance requirements. Proficiency with CAD tools and equipment layout design. What Your Role Will Look Like: The Equipment Packaging Engineer is responsible for specifying, designing, implementing, and optimizing packaging machinery and automated packaging lines used in the production of pharmaceutical and consumer health products. This role focuses on equipment performance, reliability, integration, validation, and continuous improvement to ensure operational efficiency, product quality, and compliance with cGMP and regulatory standards. Equipment & Line Design Lead the design, specification, and procurement of packaging equipment including blister machines, bottle lines, cartoners, labelers, pouching systems, serialization stations, and case packing equipment. Develop URS, equipment specifications, functional requirements, and design documentation for new or upgraded machinery. Evaluate equipment designs for manufacturability, reliability, and integration with existing systems, utilities, and facility layouts. Equipment Installation, Commissioning & Qualification Manage equipment installation, FAT/SAT, commissioning, and validation activities (IQ/OQ/PQ). Coordinate with vendors, system integrators, and internal maintenance teams to ensure equipment is installed and qualified per project requirements. Troubleshoot mechanical, electrical, and control-system issues during startup and post-launch phases. Line Optimization & Performance Improvement Analyze packaging line performance to identify productivity constraints, material handling challenges, and automation improvement opportunities. Implement upgrades that improve throughput, reduce downtime, enhance quality, and support continuous improvement goals. Perform root-cause analysis on recurring equipment issues and develop sustainable corrective actions. Technical Documentation & Compliance Develop and maintain technical documentation including equipment validations, specifications, drawings, change controls, SOPs, and preventive maintenance plans. Ensure compliance with cGMP, FDA/EMA regulations, internal quality systems, and safety standards. Support internal audits, regulatory inspections, and technical reviews related to equipment and packaging operations. Cross-Functional Collaboration Work closely with Operations, Maintenance, Quality, Engineering, EHS, and Supply Chain teams to ensure equipment readiness and operational alignment. Partner with suppliers, OEMs, and contractors to resolve equipment-related issues and evaluate new technologies. Provide technical training to operators, technicians, and maintenance staff. Required Skills/Abilities: Experience with serialization systems (track-and-trace, vision systems, coding/printing technologies). Familiarity with PLCs, HMIs, robotics, sensors, and line controls. Lean Manufacturing or Six Sigma certification. Experience leading equipment start-ups and managing vendor relationships. Knowledge of materials handling, conveyors, and automated packaging technologies.

The Project Quality Engineer is responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations. The Project Quality Engineer is responsible for providing quality project management and support for the company by working with the Senior Quality Assurance Manager to assure proper GMP compliance within Delcath Systems. PRIMARY DUTIES AND RESPONSIBILITIES: Project Management - lead continuous improvements projects. Participate on new product design teams as the design quality assurance engineer. Support design verification, process validation, software validation and test method validation. Generate procedures, specifications, and labeling as required. Support the Corrective Action and Preventive Action Program. Support the Internal Audit Program through the performance of audits as required. Support the Supplier Quality Program and perform on-site quality audits, as required. Support external regulatory audits. Understand and communicate component and finished product specification requirements. Support the Management Review process to monitor and evaluate Quality System effectiveness. Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required. A minimum of Bachelor's degree in engineering or physical sciences is preferred. A minimum of five or more years of experience in quality assurance, quality engineering, project management or related functions in an FDA regulated industry or ISO certified organization is required. Must be team oriented, with the ability work well with diverse cross-functional teams. Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.

Title: Manufacturing Technology Project Engineer The Manufacturing Technology Project Engineer is responsible for improving manufacturing processes by evaluating and implementing advanced engineering technologies, equipment and tooling. Oversee the procurement and implementation of manufacturing technologies within Deringer-Ney, Inc. to improve quality, efficiency and cost. Supervisory Responsibilities: None. Duties/Responsibilities: Identify and evaluate potential equipment and tooling suppliers, manage the sourcing process to secure high-quality equipment and tools at optimal cost and delivery terms. Prepare return of investment analysis to justify investment in selected technology, equipment and tooling. Work closely with internal teams (design, process and quality engineers, maintenance, etc.) to facilitate and manage overall project implementation through IQ/OQ/PQ process Foster strong relationships with vendors and oversee the design, development and fabrication of manufacturing equipment and tooling. Ensure manufacturing solutions meet the required quality standards, certifications, regulatory requirements, customer specifications, production timelines and budget. Support the Design Engineers by suggesting ideas to make the detail components or assemblies more cost effective and producible Required Skills/Abilities: Strong understanding of manufacturing processes (e.g. wire draw, strip rolling, stamping , machining, plastic injection molding). Knowledge of quality control standards and regulatory compliance, especially in medical and automotive sectors. Excellent communication, problem-solving, and project management skills. Ability to work collaboratively in a cross-functional team environment. Education and Experience: Bachelor's degree in materials science (metallurgy), mechanical engineering or Industrial Engineering. Minimum 5 years of manufacturing experience in production environment. Experience as a Metallurgy Manufacturing Engineer is strongly preferred. Physical Requirements: Prolonged periods of sitting or standing. Must be able to lift 15 pounds at times. Must be able to access and navigate each department at the organization's facilities.

Title: Senior Research Metallurgist The Senior Research Metallurgist provides technical expertise in areas of materials and processes in support of all areas of the company. Initiates and conducts new material, process, and product development; works directly with customers and potential customers to resolve technical problems; and assumes leadership of R&D during the absence of the R&D Manager. Supervisory Responsibilities: Yes Duties/Responsibilities: Initiate and conduct new product development, especially in the areas of new alloy formulation, materials processing and innovative use of all Deringer-Ney processes and materials. Assist with day-to-day manufacturing problems related to materials and processing. Take lead role in the development of innovative solutions to manufacturing problems. Provide technical support to the Sales and Marketing departments. Work directly with customers and prospects to select appropriate DNI products. Perform detailed failure analyses for company, customers, and prospects. Prepare well written, professional reports for both internal and external use. Provide technical training, and support of, field sales personnel. Maintain working knowledge of technological developments in both new and existing markets and keep upper management aware of potential impact of these changes. Support new product development activities of others within the company. Initiate continuous improvement and operational excellence programs within R&D and support similar programs within the organization. ADDITIONAL RESPONSIBILITIES: Supervise activities of R&D technician(s). Undertake special projects as requested by the R&D Manager. Develop and document new test methods to support improved product quality/ reliability. Required Skills/Abilities: Extensive technical understanding of company products and processes. Well-developed interpersonal skills. Excellent writing ability. Able to prepare and make effective presentations to company employees and customers. Experience & Education Requirements: Minimum - BS degree in Metallurgical Engineering, Materials Engineering, or Materials Science and Engineering. Extensive, demonstrated understanding of alloy development and material processing. Demonstrated record of preparing high quality technical reports, whitepapers, manuscripts, or patents. Required Experience: BS + 12 years industrial research experience. MS + 5 years industrial research experience; or PhD + 1 year industrial experience Outstanding candidates at lower experience levels may be considered for a Research Metallurgist position Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift 15 pounds at times. Must be able to access and navigate each department at the organization's facilities.

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

Expertise in equipment and manufacturing process, capability to support multiple process areas 3+ years of leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes. Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering . • Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance. Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization. Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency. Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within process engineering area. Participate in communications with relevant internal teams (e.g., regulatory) for management of change control. Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements. Develop contacts across a range of departments and external groups acting as engineering representative. Equipment Management Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business Essential Requirements: Bachelor's degree in Chemical or Mechanical Engineering Minimum of 3 years relevant experience. Breadth of experience to establish credibility with key stakeholders. Industry experience in a GMP environment Preferred Experience: 5 years of relevant experience Large Capital project management and execution experience Lean certification Experience with automatic process controls Root cause investigation training/ 6-simga TPM experience Experience with spray-drying technology Experience with equipment maintenance Experience with regulatory inspections and handling deviations Experience working within cross-functional teams. Has experience in change control, budget and project management, including a track record of driving continuous improvement initiatives. Project management track record of delivering projects Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps) The annual base pay for this position ranges from $97,372 - $146,058. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 22-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr

A leading medical technology company is seeking a Manufacturing Engineer II in Boston to oversee manufacturing operations and documentation. The ideal candidate will have 5-7 years of experience in engineering, strong analytical abilities, and effective communication skills. This position involves working in a fast-paced environment and requires a Bachelor's degree in Engineering. Opportunities for project management and international travel are available. #J-18808-Ljbffr

A global medical technology leader is seeking a Senior Manufacturing Engineer to perform manufacturing engineering duties. The ideal candidate should possess strong analytical skills and at least 8 years of experience in a related field, preferably in the medical device industry. Responsibilities include overseeing key process equipment, developing manufacturing documentation, and training team members. Join a company dedicated to transforming lives through innovative medical solutions. #J-18808-Ljbffr

A global medical technology leader is seeking a Manufacturing Engineer II to perform various engineering duties, including developing manufacturing documentation and ensuring product quality. The ideal candidate will have a Bachelor's degree in Engineering and 5-8 years of relevant experience, possessing strong analytical, problem-solving, and leadership skills. This role involves cross-functional collaboration, training team members, and achieving production goals. Join us to make a difference in patient health. #J-18808-Ljbffr

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

We are seeking a highly skilled Senior Process Validation Engineer with strong experience in drug product manufacturing within a CDMO (Contract Development and Manufacturing Organization) environment. In this role, you will lead validation activities-process validation, technology transfers, equipment qualification, and continued process verification-for a portfolio of client-driven drug product programs. You will work cross-functionally with Manufacturing, Quality, MS&T, and Regulatory teams to ensure processes are robust, compliant, and scalable. This is a critical, high-impact role for someone who thrives in a fast-paced, client-focused setting. Key Responsibilities Lead planning and execution of process validation activities for drug product processes (e.g., aseptic filling, lyophilization, liquid/solid dosage, compounding, filtration). Serve as the SME for drug product validation in a CDMO environment, supporting multiple client programs simultaneously. Develop validation strategies, protocols (IQ/OQ/PQ), and reports in alignment with global regulatory expectations (FDA, EMA, ICH Q8/Q9/Q10/Q11). Partner with MS&T to support tech transfer of client processes into GMP manufacturing. Drive continued process verification (CPV) and ongoing monitoring programs. Support equipment and facility qualification as needed, including URS development and FAT/SAT activities. Collaborate closely with QA to ensure audit readiness and to support regulatory submissions. Analyze process data to identify trends, optimize processes, and reduce variability. Lead investigations and CAPAs related to process or validation deviations. Serve as a technical liaison with clients, presenting validation strategies, data, and recommendations. Required Qualifications Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related discipline. 5-8+ years of process validation experience specifically within drug product manufacturing. Must have prior CDMO experience supporting client programs or multi-product operations. In-depth knowledge of validation lifecycle approaches, process characterization, and risk-based validation. Strong understanding of aseptic/sterile manufacturing, formulation, filling, or other drug product operations. Demonstrated experience working in a GMP-compliant environment with global regulatory frameworks. Excellent technical writing, communication, and client-facing skills. Preferred Qualifications Experience with aseptic processing, lyophilization, or high-potency drug products. Proven success in fast-paced, project-driven, multi-client environments. Familiarity with statistical tools for validation and CPV (e.g., Minitab). Ability to lead cross-functional teams and mentor junior engineers.

The Equipment Packaging Engineer is responsible for specifying, designing, implementing, and optimizing packaging machinery and automated packaging lines used in the production of pharmaceutical and consumer health products. This role focuses on equipment performance, reliability, integration, validation, and continuous improvement to ensure operational efficiency, product quality, and compliance with cGMP and regulatory standards. Duties and Responsibilities: Equipment & Line Design * Lead the design, specification, and procurement of packaging equipment including blister machines, bottle lines, cartoners, labelers, pouching systems, serialization stations, and case packing equipment. * Develop URS, equipment specifications, functional requirements, and design documentation for new or upgraded machinery. * Evaluate equipment designs for manufacturability, reliability, and integration with existing systems, utilities, and facility layouts. Equipment Installation, Commissioning & Qualification * Manage equipment installation, FAT/SAT, commissioning, and validation activities (IQ/OQ/PQ). * Coordinate with vendors, system integrators, and internal maintenance teams to ensure equipment is installed and qualified per project requirements. * Troubleshoot mechanical, electrical, and control-system issues during startup and post-launch phases. Line Optimization & Performance Improvement * Analyze packaging line performance to identify productivity constraints, material handling challenges, and automation improvement opportunities. * Implement upgrades that improve throughput, reduce downtime, enhance quality, and support continuous improvement goals. * Perform root-cause analysis on recurring equipment issues and develop sustainable corrective actions. Technical Documentation & Compliance * Develop and maintain technical documentation including equipment validations, specifications, drawings, change controls, SOPs, and preventive maintenance plans. * Ensure compliance with cGMP, FDA/EMA regulations, internal quality systems, and safety standards. * Support internal audits, regulatory inspections, and technical reviews related to equipment and packaging operations. Cross-Functional Collaboration * Work closely with Operations, Maintenance, Quality, Engineering, EHS, and Supply Chain teams to ensure equipment readiness and operational alignment. * Partner with suppliers, OEMs, and contractors to resolve equipment-related issues and evaluate new technologies. * Provide technical training to operators, technicians, and maintenance staff. Required Skills/Abilities: * Experience with serialization systems (track-and-trace, vision systems, coding/printing technologies). * Familiarity with PLCs, HMIs, robotics, sensors, and line controls. * Lean Manufacturing or Six Sigma certification. * Experience leading equipment start-ups and managing vendor relationships. * Knowledge of materials handling, conveyors, and automated packaging technologies. Education and Experience: * Bachelor's degree in Mechanical Engineering, Packaging Engineering, Electrical Engineering, Mechatronics, or related field. * 5-10 years of experience working with packaging equipment in the pharmaceutical, biotech, food, beverage, or consumer products industry. * Strong knowledge of packaging equipment design, automation, mechanical systems, controls, and integration. * Experience with FAT/SAT, commissioning, and qualification (IQ/OQ/PQ). * Understanding of cGMP, FDA/regulated environments, and packaging line compliance requirements. * Proficiency with CAD tools and equipment layout design. * Strong problem-solving, project management, and cross-functional communication skills. To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify. PAI Pharma is a nicotine-free campus, meaning the use of nicotine products-including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances-is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees. EEO Employer / Veteran / Disabled

Develops and delivers multi -work stream project plans with complex dependencies and numerous vendors. Is responsible for major sections of large client capacity planning, budget, and resource and materials plan. Provides individual feedback to project team members on their contributions, quality of deliverables and overall performance on the project. Demonstrated delivery of Project Engineer 2 level requirements. Demonstrated capability to deliver on the Senior Project Engineer responsibilities. Ability to mentor and guide less experienced team members. Ability to communicate effectively with clients. Proven ability to identify areas of business expansion and report to management team for follow -up. Ability to lead risk assessment activities to determine project goals for Client products. Obvious business maturity and interpersonal skills to be able to communicate effectively and collaborate. Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the clients' organization. Advanced Microsoft Project capabilities. Requirements Experience in Packaging LINES Experience with Fillers Labelizers, Case Packaging, Palletizers Installation, Start up and Validation experience Write and execute protocols Engineering tracking Serialization Experience - System used (Antares) preferred if they have this but not mandatory Benefits· High growth potential and fast -paced organization with a people -focused culture · Competitive pay plus performance -based incentive programs · Company -paid Life, Short -Term, and Long -Term Disability Insurance. · Medical, Dental & Vision insurances · FSA, DCARE, Commuter Benefits · Supplemental Life, Hospital, Critical Illness and Legal Insurance · Health Savings Account · 401(k) Retirement Plan (Employer Matching benefit) · Paid Time Off (Rollover Option) and Holidays · As Needed Sick Time · Tuition Reimbursement · Team Social Activities (We have fun!) · Employee Recognition · Employee Referral Program · Paid Parental Leave and Bereavement

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! About the Role As a Senior Packaging Engineer, you will support the development and implementation of packaging solutions for Elanco's global product development pipeline. This role is focused on development-stage products across pharmaceutical, biopharmaceutical, and vaccine portfolios, with regular collaboration across global teams in the U.S. and Europe. You will own packaging development activities for assigned projects, working closely with R&D, Manufacturing, Quality, and Regulatory partners to define, evaluate, and implement appropriate packaging solutions from early development through registration and commercial readiness. This role is well suited for a packaging engineer who enjoys hands-on project ownership, technical problem solving, and working in a regulated development environment. Your Responsibilities Own packaging development activities for assigned projects, defining and implementing appropriate primary, secondary, and tertiary packaging solutions from early development through commercialization. Serve as the packaging Subject Matter Expert on cross-functional project teams, with exposure to sterile and non-sterile packaging systems. Partner with R&D and Manufacturing to evaluate technical feasibility, processability, and transfer of packaging solutions into commercial production. Plan, execute, and interpret packaging tests and machine trials, evaluate data, draw conclusions, and support documentation and registration activities. Author packaging registration documents and interact with the registration team as appropriate. Evaluate new packaging materials, technologies, and suppliers to support compliant and efficient development solutions. Ensure packaging activities align with internal standards, external guidelines, and regulatory requirements. Collaborate effectively with global teams and external partners to support development timelines. What You Need to Succeed (Minimum Qualifications) Master's degree in Packaging Technology or a related discipline, or a bachelor's with 5 plus years of relevant/equivalent experience. Minimum of 5 years of experience supporting pharmaceutical or biopharmaceutical drug product development. Experience with parenteral and/or sterile packaging and associated regulatory expectations. Strong knowledge of packaging materials, packaging development activities, and pharmaceutical manufacturing processes. Familiarity with GMP principles and regulated development environments. Strong written and verbal communication skills, with the ability to work effectively across cross-functional and global teams. What Will Give You a Competitive Edge (Preferred Qualifications) Experience supporting pharmaceutical, biopharmaceutical, or vaccine development programs. Experience working with sterile manufacturing environments and container closure integrity (CCI) concepts. Prior experience authoring or supporting regulatory submissions related to packaging. Ability to manage multiple development projects in a global, cross-functional environment. Demonstrated adaptability and ability to learn in a dynamic development setting. Additional Information • Travel: 10-20% annually • Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment 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

Career CategoryScientificJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Senior Associate - Cellular Sciences - Biosafety Development Group What you will do Let's do this! Let's change the world! In this vital role you will join our Biosafety Development (BSD) group. The Senior Associate will support ensuring patient safety by performing sterile filtration validation studies for Amgen's pharmaceutical products. Also, they may partake in technology development for detection and identification of bacterial adventitious agents. Primary focus will be on performing GMP validation studies for sterile filtration via Standard Operating Procedures and qualified detection methods using model bacterial strains. These studies will support IND and MA filings to the FDA. Test articles are generated with protein purification processes and will require preliminary testing to assess matrix interference with bacterial health. Assays performed for the detection of bacteria may include traditional detection methods and/or molecular techniques. Responsibilities may include the following: Leading and executing GMP bacterial filtration retention studies to support IND and MA filings to the FDA. Utilizing traditional or molecular assays for the detection of bacterial adventitious agents. Applying filtration knowledge and techniques to troubleshoot problems during execution of studies. Assay method development and qualification. Training other employees. Managing materials and supply inventory. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of Scientific experience OR Associate's degree and 4 years of Scientific experience OR Bachelor's degree and 2 years of Scientific experience OR Master's degree Preferred Qualifications: Hands on experience with purification processes, especially filtration. Previous work assessing and validating filtration loading and performance using small-scale model devices is desired. Hands on experience with bacterial detection techniques, including molecular biology methods (e.g., qPCR); method development experience a plus. Possess strong written and verbal communication skills and a desire to learn new scientific concepts. Work as a member of a small team to follow and develop methods. Demonstrate good planning and project execution skills. Clearly and concisely interpret and present data. Ability to understand, apply and evaluate biological and mathematical principles. Excellent sterile technique. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 86,613.00 USD - 104,742.00 USD

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Associate Engineer, Process Development** **What you will do** Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen's FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network. Additionally, the Process Development Associate will use out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in downstream protein purification, thereby further contributing to the integrated group. + Apply a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up + Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management + Ensure safety and compliance of process development activities + Provide process on floor process support as required + Provide support for regulatory filing, inspection, and other CMC activities **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications. **Basic Qualifications:** + High school diploma / GED and 6 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR + Associates and 4 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR + Bachelor's degree **Preferred Qualifications:** + Master's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences + Some experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) + Understanding of protein purification/separation principles + Understanding of process scale-up, technology transfer, troubleshooting, and complex investigation + Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders + Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Process Development Senior Associate** **What you will do** Let's do this. Let's change the world. In this vital role you will work in a team environment to contribute to drug substance process development + Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors + Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed + Document experimental data in lab notebooks + Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings) + Contribute to technology development projects to seek continuous improvement in reliability and efficiency **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications. **Basic Qualifications:** + High school diploma / GED and 6 years of life sciences industry experience OR + Associate's degree and 4 years of Quality Control experience OR + Bachelor's degree and 2 years of Quality Control experience OR + Master's degree **Preferred Qualifications:** + Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred. + Relevant hands-on lab experience in cell culture or protein purification. + Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment + Experience in Design of Experiments and statistical analysis is a plus. + Good oral and written communication skills. + Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Process Development Senior Associate What you will do Let's do this. Let's change the world. In this vital role you will work in a team environment to contribute to drug substance process development Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed Document experimental data in lab notebooks Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings) Contribute to technology development projects to seek continuous improvement in reliability and efficiency What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of life sciences industry experience OR Associate's degree and 4 years of Quality Control experience OR Bachelor's degree and 2 years of Quality Control experience OR Master's degree Preferred Qualifications: Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred. Relevant hands-on lab experience in cell culture or protein purification. Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment Experience in Design of Experiments and statistical analysis is a plus. Good oral and written communication skills. Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 86,613.00 USD - 104,742.00 USD

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview As a Process Engineer I, you'll launch your career in chemical engineering with the support of highly experienced engineers and scientists who are eager to mentor and guide you. In this role, you'll be immersed in every stage of bringing new products from the laboratory to full-scale manufacturing, gaining hands-on experience with batch processes and unit operations such as reactions, distillation, extraction, filtration, and drying. Because we are a global contract development and manufacturing organization, you'll have the unique opportunity to work on several different chemical processes each year and collaborate directly with pharmaceutical clients from around the world. This role is designed to accelerate your professional growth, giving you the chance to learn, contribute, and make a real impact early in your career. Reporting to a Senior Manager, Process Engineering, the Process Engineer I is part of a team responsible for the cGMP manufacture of active pharmaceutical ingredients. The engineer will apply their knowledge of chemical engineering fundamentals to assist project teams translating new chemical processes to manufacturing. Projects include small-scale development, technology transfer, pilot-scale production, validation, and support of commercial manufacturing. Responsibilities Under the guidance of senior engineers and scientists: Perform scaling calculations for unit operations, assisting with the conceptual process design. Participate in process reviews for operability, safety, and quality. Play a support role, providing information to external clients and internal stakeholders. Support production campaigns through in-person observation. Analyze production and laboratory data to assist with process understanding. Assist with quality investigations and corrective action / preventative action implementation. Support process improvement projects to reduce cycle time, increase yield, and improve quality. Draft manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports. Qualifications/Skills Applied Math and Science: A strong understanding of the core chemical engineering fundamentals (thermodynamics, heat transfer, mass transfer, transport, kinetics, etc. ). Data Analysis, Visualization, Troubleshooting: The ability to analyze data from various sources, including sensors and experiments, to identify trends, troubleshoot issues, and improve efficiency. Process Simulation and Modeling: With training and support from senior engineers, use software (spreadsheets, programming, simulators) to model chemical unit operations and processes. Process Safety and Risk Management: With training and support from senior engineers, assess and manage risks associated with chemical processes, ensuring the safety of personnel and the environment. Process Scale Up & Equipment knowledge: With training and support from senior engineers, assess equipment capability of key processing equipment (reactors, filters, heat exchangers) with respect to process fit. Problem-Solving: With training and support from senior engineers, identify, analyze, and solve complex problems related to chemical processes and plant operations. Includes investigations. Technical Writing & Communication: The ability to explain technical concepts clearly and accurately to technical and non-technical audiences. Attention to Detail: Be meticulous and pay close attention to detail to ensure accuracy and quality. Adaptability: The ability to adapt to changing priorities, new technologies, and unexpected challenges is important. Time Management: Ability to handle key assignments, meeting deadlines with supervision. Education, Experience & Licensing Requirements B. S. degree in Chemical Engineering or related field. Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-RD1B. S. degree in Chemical Engineering or related field. Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred. Under the guidance of senior engineers and scientists: Perform scaling calculations for unit operations, assisting with the conceptual process design. Participate in process reviews for operability, safety, and quality. Play a support role, providing information to external clients and internal stakeholders. Support production campaigns through in-person observation. Analyze production and laboratory data to assist with process understanding. Assist with quality investigations and corrective action / preventative action implementation. Support process improvement projects to reduce cycle time, increase yield, and improve quality. Draft manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports.