Sustaining Engineer jobs at IPS-Integrated Project Services

Contract Validation Engineer - Indianapolis, IN (2 year contract) We are seeking Validation Engineers to join a leading global organization committed to advancing healthcare solutions. Key Responsibilities Execute validation activities with a strong focus on drug-handling processes to maintain audit readiness. Validate critical process parameters for aseptic handling, packaging integrity, and contamination control. Oversee qualification of equipment and systems supporting drug-handling processes, including cleanrooms and controlled environments. Develop and maintain validation documentation aligned with GMP, FDA, and EU standards, ensuring data integrity and regulatory compliance. What We're Looking For Experience in pharmaceutical validation, particularly in aseptic and drug-handling environments. Strong understanding of regulatory requirements and quality standards. Detail-oriented with excellent documentation and problem-solving skills.

#LI-Onsite This position will be located at Durham, NC and will not have the ability to be located remotely. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. A Bioprocess Engineer Downstream/Fill-Finish plays a critical role in the manufacturing operations at a plant or site. This position is pivotal in ensuring the smooth execution of production processes, organizing and running operations effectively, and continuously improving the manufacturing workflow. Role Responsibilities: Performs commercial and clinical manufacturing operations on-site, including purification (downstream), fill-finish (drug product, visual inspection, packaging), media/buffer preparation, and any additional supporting activities. Troubleshoot equipment, collaborate with other business units to aid in manufacturing-led deviations, standardize equipment, and clean production areas. Assists in identifying root causes, implementing solutions, and verifying the effectiveness of those solutions. Contributes to the creation and ongoing maintenance of all pertinent equipment policies and procedures. Acquires and applies aseptic techniques relevant to cell culture, recovery, purification, aseptic fill/finish (upstream and downstream). Supports product requirements to ensure that all products are manufactured according to plan. Learns cGMP and cGDP protocols, ensures accurate completion of cGMP documentation, maintains current training, and adheres to all quality standards. Maintains quality standards to meet cGMP requirements, CFRs, and internal company policies directly related to the manufacturing process. Collaborates with the Quality department to ensure a compliant manufacturing environment Shift: This role is a 2-2-3 day shift position. 5:45am-6:15pm Role Requirements: **The level of the role will be determined by the years of relevant experience. For Bioprocess Engineer I - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience; For Bioprocess Engineer II - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 2 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR four (4) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree; For Bioprocess Engineer III - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 4 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR six (6) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree Excellent oral and written communication skills Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between: for Bioprocess Engineer I, $22.84 and $42.46; for Bioprocess Engineer II/III, $32.12 and $59.62, per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Company will not sponsor visas for this position. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $66,800.00 - $124,000.00 Skills Desired Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, General Hse Knowledge , Good Documentation Practice, Installations (Computer Programs), Iso (International Organization For Standardization), Job Description, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduler

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small/lab scale to large/commercial scale and from external partners. The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors. This role is based in Sanford, NC. **Essential Job Responsibilities:** + Provide process engineering, design, and on-going improvements for drug substance manufacturing processes + Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities + Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization + Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners + Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and + Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation + Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements + Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports + Support/lead tech transfer, equipment commissioning, training, and validation activities + Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing + Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems + Support process deviation investigations, root cause analysis, and CAPAs + Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction + Will support and demonstrate data integrity standards to ensure data of highest quality **Qualifications** **Required:** + MS in Engineering or Life Sciences, entry level, or BS with 2 years of relevant technical experience. + Sound technical knowledge of upstream or downstream bioprocessing with a background in biologic or ATMP process development, technical transfer, and/or manufacturing + Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers + Ability to think critically, and demonstrated troubleshooting and problem-solving skills + Demonstrated experience with interpreting complex data sets + Effective scientific communication skills, including technical writing and presentation of technical content to diverse audiences + Capable of working independently with minimal supervision + Desire to work within a fast-paced environment under challenging timelines + Attention to detail supported by good time management and organizational skills + Proficiency with MS Office (Excel, PowerPoint, Word, Project, and Visio) **Preferred:** + Experience in gene therapy and/or monoclonal antibody manufacturing, scale-up/scale-down, and tech transfer + Understanding of industry expectations with respect to phase appropriate requirements while advancing products from pre-clinical to commercial state + Experience with statistical analysis and associated software (e.g., JMP) + Experience with single-use equipment and systems + Knowledge of cGMPs and good documentation practices (GDP) + Experience with process equipment and facility design engineering such as hydraulic calculations, equipment sizing, process simulations, Heat and Material Balances (H&MB), Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and User Requirement Specification (URS) development + Experience with process validation and lifecycle management + Experience supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ **Working Environment:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + As assigned, this position may be required to work during non-traditional work hours to support critical business operations + This is an on-site role working in a cGMP regulated manufacturing facility with some hybrid flexibility + On occasion, this role may travel to other Astellas sites and/or vendors (0-5%) **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program **\#LI-TR1** Category Sanford TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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

Engineer, Process (Fermentation) Onsite As an Engineer, Process in Fermentation, you will provide technical direction for a defined portion of the production process and share responsibility for departmental performance in safety, health, environment, quality, and production. Working independently, you will prioritize tasks based on process needs. You will collaborate closely with the production team-including the Production Manager, Process Engineers, Technical Coordinator, and Operators-and represent Production on project work, partnering with Senior Engineers, Maintenance, and the Director of Operations. At times, you may supervise project teams. As the ARA process owner, you will ensure volumes and quality meet business requirements. At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace. Key Responsibilities: * Observes, analyzes and interprets information from process operations to identify areas for optimization. Assists Technicians with establishing and maintaining predictive/preventative programs for the area. Analyzes and solves, or manages the resources to address, technical/operational problems related to the assigned process. Leads and facilitates process troubleshooting. * Conceives, plans, develops, and recommends proposals for optimizing production capacity/capability in assigned process. May manage small capital projects for area and is a resource on large projects. * Assists in setting, tracking and meeting department goals. Supports plant and corporate initiatives as outlined in the manufacturing plan. Promotes teamwork and cooperation. * Adheres to equipment/material specifications. Follows the change control process and ensures that change control documentation (e.g. P&ID CAD drawings, red lines, PSM, SOPS, ISO etc.) is completed for process changes. * Reviews and signs batch records and reports non-conformances. Participates in and leads investigations into non-conformances and completes investigation documentation. * Implements SHEQ policy compliance within work group. Participates in and leads investigations of safety/environmental incidents including root cause analysis and the development and execution of corrective actions. Participates in and leads HAZOP/pre-startup safety reviews. Responsible for insuring regulatory compliance for process critical control points (e.g., vent control devices) as assigned. * Other duties assigned by Belvidere leadership. We Bring: * Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen * A chance to impact millions of consumers every day - sustainability embedded in all we do * A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next * Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership * A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on. * A community where your voice matters - it is essential to serve our customers well. You Bring: * BS in Chemical Engineering (or rel. technical discipline) required. * 1-2 years relevant experience required, preferably in the chemical industry. * Knowledge and understanding of personal computers, SAP, quality systems (cGMPs, ICHQ7A, ISO), environmental, regulatory and safety compliance. * Knowledge of relevant Manufacturing Excellence work processes such as Asset Utilization and Operate Plant Normal. * Knowledge of relevant Safety, Health, and Environmental practices such as PHA, RCA, etc. * Must have good communications skills and the ability to present ideas effectively. Demonstrates ability to manage multiple projects and work in a team environment. * Where necessary, should be knowledgeable in the operation of process control instruments and systems. * Must be available to support shift, weekend and holiday schedules as required. The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary Range: $64,300 - $118,700. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, Belonging and Equal Opportunity Statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency Statement Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency's fees, percentages or similar.

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles * At CAI, we are committed to living our values-both professionally and personally: * We act with integrity * We serve each other * We serve society * We work for our future * We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities 1. Technical Responsibilities * Develop documentation for CQV activities * Write and execute protocols (field verification) * Develop summary reports at client sites 2. Areas of Focus * Pharmaceutical facilities * Utilities * Equipment 3. Project & Team Management * Plan and coordinate work * Direct small teams in document development and/or execution Qualifications and Experience * Bachelor's degree in a science or engineering field (or equivalent experience) * 2-4 years' experience in commissioning and qualification in a regulated industry * Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus * Preferred experience in: * Facilities and equipment startup * Walk-downs and troubleshooting * Utilities (WFI, RO, HVAC) * Upstream/downstream processing * Purification, recovery * Building automation * Pharmaceutical manufacturing processes Critical Competencies Influence Strategy * Pursues initiatives aligned with organizational strategy * Identifies strategic, innovative solutions * Anticipates emerging customer/market needs Satisfy the Customer * Understands and anticipates customer needs * Delivers high-quality solutions and service * Proactively maintains satisfaction and loyalty Plan for Success * Aligns business strategies with actionable plans * Anticipates risks and builds contingency plans * Secures resources for goal achievement Pursue Execution * Prioritizes time and resources effectively * Holds self and others accountable * Acts to overcome obstacles and improve quality Tailor Communication * Communicates clearly and professionally * Adjusts style to fit the audience * Explains technical concepts effectively Build Partnerships * Builds networks across functions * Encourages collaboration and breaks down silos * Involves stakeholders in decisions Influence Others * Builds support with sound rationale * Gains buy-in from decision makers * Encourages innovative thinking Develop Self and Others * Enhances interpersonal relationships * Models integrity and company values * Seeks out growth and breakthrough opportunities #LI-MV1 $72,800 - $80,100 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: * Comprehensive Health Insurance coverage * 24 days of Paid Time Off * ESOP/401K - 15% Company Contribution (US Only) * Company paid Life Insurance * Company paid Long Term Disability We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Validation Engineer. Job Description: The Validation Engineer will demonstrate his/her knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes and work independently in a matrix team environment, influencing team decisions, and exercising sound judgement in determining compliant and robust validation approaches. He/she will have the ability to multi-task with a demonstrated track record in meeting deliverable timelines and must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving and is a strong team player aligned with company corporate values. Will have good interpersonal, verbal, and written communication skills and has the ability to function effectively and independently in a fast-paced and dynamic environment. He/she is self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed. Has the ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs. Is an expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills and understands basic statistics, acceptance sampling, and is familiar with statistics software. Demonstrates hands on experience with facility/equipment/utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment and with CIP/SIP cycle development. Responsibilities: Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning validation, computer system validation and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis. As needed coordinate and provide directions to contract personnel performing validation activities. Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort. Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports. Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization) development activities. Support periodic requalification and revalidation effort. Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA. Support gap assessment/closure, corrective actions, and compliance remediation related to Validation. As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections. As assigned mentor and manage fulltime validation engineers/specialist and contractors. Education and/or Experience: Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus. Minimum 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 3 of 7 validation core expertise. Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation. Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820). Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports). Experience with customer and regulatory inspection. Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach. Hands on validation experience in developing validation documentation and field execution. Project Management experience is a plus. Aerosol production experience is a plus. Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. ************** Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

Validation Engineer Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Validation Engineer. Job Description: The Validation Engineer will demonstrate his/her knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes and work independently in a matrix team environment, influencing team decisions, and exercising sound judgement in determining compliant and robust validation approaches. He/she will have the ability to multi-task with a demonstrated track record in meeting deliverable timelines and must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving and is a strong team player aligned with company corporate values. Will have good interpersonal, verbal, and written communication skills and has the ability to function effectively and independently in a fast-paced and dynamic environment. He/she is self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed. Has the ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs. Is an expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills and understands basic statistics, acceptance sampling, and is familiar with statistics software. Demonstrates hands on experience with facility/equipment/utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment and with CIP/SIP cycle development. Responsibilities: Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning validation, computer system validation and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis. As needed coordinate and provide directions to contract personnel performing validation activities. Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort. Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports. Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization) development activities. Support periodic requalification and revalidation effort. Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA. Support gap assessment/closure, corrective actions, and compliance remediation related to Validation. As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections. As assigned mentor and manage fulltime validation engineers/specialist and contractors. Education and/or Experience: Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus. Minimum 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 3 of 7 validation core expertise. Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation. Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820). Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports). Experience with customer and regulatory inspection. Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach. Hands on validation experience in developing validation documentation and field execution. Project Management experience is a plus. Aerosol production experience is a plus. Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. ************** Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application. Powered by JazzHR qGoMOUNTwT

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles * At CAI, we are committed to living our values-both professionally and personally: * We act with integrity * We serve each other * We serve society * We work for our future * We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities 1. Technical Responsibilities * Develop documentation for CQV activities * Write and execute protocols (field verification) * Develop summary reports at client sites 2. Areas of Focus * Pharmaceutical facilities * Utilities * Equipment 3. Project & Team Management * Plan and coordinate work * Direct small teams in document development and/or execution Qualifications and Experience * Bachelor's degree in a science or engineering field (or equivalent experience) * 2-4 years' experience in commissioning and qualification in a regulated industry * Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus * Preferred experience in: * Facilities and equipment startup * Walk-downs and troubleshooting * Utilities (WFI, RO, HVAC) * Upstream/downstream processing * Purification, recovery * Building automation * Pharmaceutical manufacturing processes Critical Competencies Influence Strategy * Pursues initiatives aligned with organizational strategy * Identifies strategic, innovative solutions * Anticipates emerging customer/market needs Satisfy the Customer * Understands and anticipates customer needs * Delivers high-quality solutions and service * Proactively maintains satisfaction and loyalty Plan for Success * Aligns business strategies with actionable plans * Anticipates risks and builds contingency plans * Secures resources for goal achievement Pursue Execution * Prioritizes time and resources effectively * Holds self and others accountable * Acts to overcome obstacles and improve quality Tailor Communication * Communicates clearly and professionally * Adjusts style to fit the audience * Explains technical concepts effectively Build Partnerships * Builds networks across functions * Encourages collaboration and breaks down silos * Involves stakeholders in decisions Influence Others * Builds support with sound rationale * Gains buy-in from decision makers * Encourages innovative thinking Develop Self and Others * Enhances interpersonal relationships * Models integrity and company values * Seeks out growth and breakthrough opportunities #LI-MV1 $72,800 - $80,100 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: * Comprehensive Health Insurance coverage * 24 days of Paid Time Off * ESOP/401K - 15% Company Contribution (US Only) * Company paid Life Insurance * Company paid Long Term Disability We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Details Experienced Crawfordsville ATB - Crawfordsville, IN Full Time 4 Year or Bachelor Degree Up to 25% EngineeringDescription Closure Systems International, Inc. (CSI) is a global leader in plastic and aluminum closure design, manufacturing and high-speed capping equipment / application systems. Approximately 90+ billion closures are produced annually in CSI's 25+ manufacturing sites, strategically located in 20+ countries throughout the globe. CSI integrates innovative closure technology, high-performance equipment and expert technical services and training support to help customers all over the world maximize their profits. These integrated closure and capping solutions deliver a total system of unsurpassed customer value and reliability. Duties and Responsibilities CSI is looking for a materials engineer to join the global material science group. This position will report to the director of materials development. The individual will have the responsibility to develop the next generation closure materials. Next generation materials is a subset of two of our six strategic corporate values (sustainability and innovation) for our business and a key part of our future success. Next generation materials include cost savings initiatives, technology enablers and sustainability improvements. Technology enablers are material developments that allow CSI to achieve new value added closure properties and are critical for growth in new markets. CSI is a leader in commercializing sustainability solutions for the closure industry. The individual will have the responsibility for concept to deployment support of R&D projects. In this role, one will get experience working closely with sales, marketing, manufacturing, engineering, process and performance laboratory, and procurement, as well as external partners such as suppliers and third party laboratories. The projects will focus on processes and materials used in the manufacture of closures / bottle caps. The skilled candidate will design and develop methods to understand underlying principles, such as polymer structure-property relationships, that dictate the performance of the materials in closures. The candidate will demonstrate initiative and creativity and will develop materials platforms by formulating and commercializing new polymer blends. The individual will interact across a broad range of levels, expertise, geographic regions as well as stay up-to date on the new developments in technical and patent literature. There will be a focus on project management and deployment for the North America business. The candidate will be responsible for commercialization of key materials initiatives. The candidate will drive materials qualifications at our plants and our customers, including planning, coordination and execution of molding trials, closure performance testing, and materials testing. The individual will be responsible to help with root cause analysis of material quality issues. The position will be located out of Crawfordsville, IN, which is close to both West Lafayette and Indianapolis. Educational and Other Skill Requirements Educational and Other Skill Requirements B.S. or an M.S. degree with experience in Chemical Engineering, Materials Engineering, Mechanical Engineering, Polymer Science or related discipline 2-5 years of expertise in polyolefin polymers (LLDPE, HDPE, PP, EVA) and polyolefin blends, plastic packaging, polymer additives, color science, polymer composites, and/or polymer processing Hands on experience in polymer blends development Experience in analytical testing methods including DSC, FTIR, GC-MS, permeability testing, polymer mechanical property testing is desired Knowledge of injection and compression molding is desired Knowledge and previous experience in the caps and closures market is desired Self-driven, hands-on, practical approach to problem-solving Intellectual curiosity, innovative outlook and ability to develop new material platforms Ability to organize and focus activities around diverse program needs Project management skills with proven track record of successfully leading projects from concept to deployment. Knowledge and use of design for six sigma / statistical data analysis with respect to R&D is preferred Good interpersonal communication skills for working within a matrix team environment Clear communication and knowledge of Spanish is a plus 8 hour days, with occasional after hours work; 10% travel

About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. What we offer you: * Leading pay and annual performance bonus for all positions * All employees enjoy generous paid time off including 14 paid holidays * Health Insurance, Dental Insurance, Vision Insurance - effective day one * Guaranteed 8% 401K contribution plus individual company match option * Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave * Free access to Novo Nordisk-marketed pharmaceutical products * Tuition Assistance * Life & Disability Insurance * Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to Manager, Technical Support. Essential Functions * Coach & mentor peers, Engineering personnel & Process Maintenance Technicians. * Support technical development of Process Maintenance Technicians & Technical Area Specialists. * Employ advanced cLEAN tools within the main areas of problem solving, project & change management. * Lead cross-functional process improvements. * Develop plans to improve the performance of a process or set of systems, using green belt concepts. * Develop & manage project budget for improvements for a process or set of systems. * Support event response activities. * Support implementation of better practices & participate in sharing knowledge across all OFP sites for improvement projects. * Maintain & establish standards for procedures & maintenance plans. * Support global OFP collaboration initiatives. * Additional accountabilities, as required. Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Qualifications * Bachelor's Degree in engineering/related field or an equivalent combination of experience & education required. * Minimum of five (5) years of engineering experience in maintenance, design, process improvement, or Six Sigma Green Belt certification or equivalent preferred. * Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), & Reliability Centered Maintenance (RCM) preferred. * Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams preferred. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

The Validation Engineer will provide direct validation support to pharmaceutical development and manufacturing operations. This role performs validation activities accurately and completes documentation fully and compliantly.Key Responsibility Areas• Oversee Site Master Validation Program: Provide input and administration of the site master validation program as well as assist in maintaining the site validation master plan while following validation policies; maintain validation life cycle approach for site• Pharmaceutical Validation: Author/Execute process validation protocols and validation summary reports; perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification Specific ResponsibilitiesResponsibilities include, but are not limited to:Cleaning Validation• Collaborate with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product• Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.• Collaborate with the cleaning verification and validation analytical group to develop and draft cleaning verification and validation protocols.• Review protocols, residue limits, reports and cleaning verification and validation summary packages.• Review new and/or updated Master Batch Records to evaluate impact on Cleaning Validation Program.• Provide technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds.• Advise on equipment improvements and/or replacements. Equipment/Utilities Qualification• Author/review URS and FRS documentation• Author/review equipment qualification protocols and summary reports• Author/review executed equipment qualification protocols and summary reports• Assist with the execution of equipment qualification protocols.• Production Oversight During Validation Events• Work to ensure validation documentation becomes part of the site's GMP documentation database• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility Key Competencies/Requirements• Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others• Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems• Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services• Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates• Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas• Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people• Attentive to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled• Interpersonal: Develop and maintain effective relationships with others; relate well to people from varied backgrounds and in different situations; show understanding, courtesy, tact, empathy, concern, and politeness Qualifications• Bachelor's degree in a Technical or Life Science• 5 - 7 years of validation experience in pharmaceutical manufacturing• Knowledgeable in cGMPs, ISO, SUPAC, and current FDA and industry standards.

The Validation Engineer will provide direct validation support to pharmaceutical development and manufacturing operations. This role performs validation activities accurately and completes documentation fully and compliantly. Key Responsibility Areas • Oversee Site Master Validation Program: Provide input and administration of the site master validation program as well as assist in maintaining the site validation master plan while following validation policies; maintain validation life cycle approach for site • Pharmaceutical Validation: Author/Execute process validation protocols and validation summary reports; perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification Specific Responsibilities Responsibilities include, but are not limited to: Cleaning Validation • Collaborate with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product • Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development. • Collaborate with the cleaning verification and validation analytical group to develop and draft cleaning verification and validation protocols. • Review protocols, residue limits, reports and cleaning verification and validation summary packages. • Review new and/or updated Master Batch Records to evaluate impact on Cleaning Validation Program. • Provide technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds. • Advise on equipment improvements and/or replacements. Equipment/Utilities Qualification • Author/review URS and FRS documentation • Author/review equipment qualification protocols and summary reports • Author/review executed equipment qualification protocols and summary reports • Assist with the execution of equipment qualification protocols. • Production Oversight During Validation Events • Work to ensure validation documentation becomes part of the site's GMP documentation database • Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility Key Competencies/Requirements • Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others • Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems • Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services • Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates • Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas • Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people • Attentive to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled • Interpersonal: Develop and maintain effective relationships with others; relate well to people from varied backgrounds and in different situations; show understanding, courtesy, tact, empathy, concern, and politeness Qualifications • Bachelor's degree in a Technical or Life Science • 5 - 7 years of validation experience in pharmaceutical manufacturing • Knowledgeable in cGMPs, ISO, SUPAC, and current FDA and industry standards.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small/lab scale to large/commercial scale and from external partners. The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors. This role is based in Sanford, NC. Essential Job Responsibilities: Provide process engineering, design, and on-going improvements for drug substance manufacturing processes Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports Support/lead tech transfer, equipment commissioning, training, and validation activities Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems Support process deviation investigations, root cause analysis, and CAPAs Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction Will support and demonstrate data integrity standards to ensure data of highest quality

Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects. Essential Functions: Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study. Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects. Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements Coordinate/oversee the development of new processes or troubleshoot existing ones Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits Additional Responsibilities: Initiation of Change Controls and Planned Deviations when required Education: Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred Experience: 2 years or more in Pharmaceutical/Manufacturing Industry Skills: Excellent verbal and written communication skills - Advanced Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced Specialized Knowledge: Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals. The salary for this position ranges from $80,000 to $95,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The Manufacturing Engineer I will provide sustaining engineering activities in the Zoetis Diagnostic & Biodevice (Dx/BD) platform. Assignments may include, but are not limited to, support of manufacturing operations, process characterization and optimization, change control projects, and engineering support of non-conformances and CAPAs. The engineer will provide support for strategic capital projects under the direction of a project lead. POSITION RESPONSIBILITIES Participate in projects relating to the development and optimization of production processes, including plant design, process equipment/workflows, material handling and automation. Provide engineering support to maintain production equipment and tooling. Support product variant projects to transfer product designs from development to commercial manufacture. Evaluate existing manufacturing processes for improvements in capacity, efficiency and product quality in alignment with business needs. Support activities to validate new or modified equipment and processes. Conduct testing of alternate materials to study their impact to product performance. Provide engineering support to troubleshoot and assess root cause for quality deviations that occur during manufacturing operations. Support continuous improvement projects. Create/update Standard Operating Procedures and manufacturing Work Instructions. Prepare Material Specification Sheets and manufacturing Bill of Materials. EDUCATION AND EXPERIENCE Education: BS in a field of engineering (Mechanical or Electrical Engineering preferred) Experience: > 5 years experience in a regulated manufacturing environment, preferably in the diagnostics or biodevice industries. Functional understanding of common electromechanical components. Experience with automated control systems. Proven experience in the application of engineering principles to the design and improvement of manufacturing processes. Relevant experience in the design and fabrication of production tooling. Experience in optimizing production workflows in increase productivity and reduce waste. TECHNICAL SKILLS and COMPETENCIES Able to quickly learn new processes Proven ability to identify, assess and solve complex problems Able to analyze process data for trends and effects Application of Lean 6-Sigma tools Experienced in AutoCAD and SolidWorks Understanding of cGMP Able to work in a team and independently Attention to detail Good written and oral communication skills Proficient in English Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles * At CAI, we are committed to living our values-both professionally and personally: * We act with integrity * We serve each other * We serve society * We work for our future * We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities 1. Technical Responsibilities * Develop documentation for CQV activities * Write and execute protocols (field verification) * Develop summary reports at client sites 2. Areas of Focus * Pharmaceutical facilities * Utilities * Equipment 3. Project & Team Management * Plan and coordinate work * Direct small teams in document development and/or execution Qualifications and Experience * Bachelor's degree in a science or engineering field (or equivalent experience) * 2-4 years' experience in commissioning and qualification in a regulated industry * Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus * Preferred experience in: * Facilities and equipment startup * Walk-downs and troubleshooting * Utilities (WFI, RO, HVAC) * Upstream/downstream processing * Purification, recovery * Building automation * Pharmaceutical manufacturing processes Critical Competencies Influence Strategy * Pursues initiatives aligned with organizational strategy * Identifies strategic, innovative solutions * Anticipates emerging customer/market needs Satisfy the Customer * Understands and anticipates customer needs * Delivers high-quality solutions and service * Proactively maintains satisfaction and loyalty Plan for Success * Aligns business strategies with actionable plans * Anticipates risks and builds contingency plans * Secures resources for goal achievement Pursue Execution * Prioritizes time and resources effectively * Holds self and others accountable * Acts to overcome obstacles and improve quality Tailor Communication * Communicates clearly and professionally * Adjusts style to fit the audience * Explains technical concepts effectively Build Partnerships * Builds networks across functions * Encourages collaboration and breaks down silos * Involves stakeholders in decisions Influence Others * Builds support with sound rationale * Gains buy-in from decision makers * Encourages innovative thinking Develop Self and Others * Enhances interpersonal relationships * Models integrity and company values * Seeks out growth and breakthrough opportunities #LI-MV1 $72,800 - $80,100 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: * Comprehensive Health Insurance coverage * 24 days of Paid Time Off * ESOP/401K - 15% Company Contribution (US Only) * Company paid Life Insurance * Company paid Long Term Disability We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects. Essential Functions: * Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study. * Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects. * Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements * Coordinate/oversee the development of new processes or troubleshoot existing ones * Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits Additional Responsibilities: * Initiation of Change Controls and Planned Deviations when required

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: OT Cybersecurity Engineer - Manufacturing As the OT Cybersecurity Engineer, you will safeguard Elanco's Clinton manufacturing environment by leading cybersecurity governance, risk management, and incident response for operational technology (OT) systems. In this role, you'll be responsible for protecting critical OT infrastructure, driving compliance with global standards, and partnering across engineering, information security, and automation teams to improve system reliability and resilience. Your Responsibilities: Lead OT Cybersecurity Program Delivery - Own site-level program execution, including disaster recovery planning, backup/restore, endpoint protection, OT security standards gap assessments, and incident response. Ensure Security Compliance & Risk Mitigation - Align OT systems with corporate cybersecurity policies and global standards; maintain asset inventories, manage secure remote access, and partner with Quality for compliance optimization. Advance OT Security Operations - Monitor and address emerging cyber threats, contribute to global security initiatives, provide data for KPIs, and act as site resource for new OT security technologies and practices. Guide & Mentor Teams - Train process automation and business partners on cybersecurity best practices, mentor staff on compliance processes, and actively participate in the Automation Community of Practice. Drive Project & Financial Management - Lead planning and execution of OT cybersecurity projects, coordinate site and contract resources, manage budgets and schedules, and resolve issues to minimize downtime and business risk. What You Need to Succeed (minimum qualifications): Education: BS or MS in Engineering (or equivalent technical discipline). Required Experience: Minimum 10 years of experience, including hands-on work with ICS systems (Rockwell or Emerson preferred) and prior experience in regulated industries (FDA, EMA/EU GMP, Animal Health, Pharma, or Biotech). Top Skills: Strong project management and leadership capabilities, combined with excellent communication, organization, and time management skills. What Will Give You a Competitive Edge (preferred qualifications): Demonstrated expertise in OT system security, governance, and compliance. Strong technical depth and curiosity with proven decision-making skills. Experience influencing technical and organizational decisions across functions. Track record of successful collaboration within global or network-level teams. Proven ability to build confidence in cybersecurity initiatives with both technical and business stakeholders. Additional Information: Location: Clinton, IN Manufacturing Site Don't meet every single requirement? Studies have shown underrepresented 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