- Twist BioScience (South San Francisco, CA)
- …The Director will serve as the primary technical and strategic expert for all MES-related initiatives.Key ResponsibilitiesStrategic Leadership & Architecture: Define ... feature enhancement of existing MES functionalities, identify opportunities for process automation, electronic batch record optimization, and advanced data… more
- Travere Therapeutics (San Diego, CA)
- …processes are a must; combination drug product development experience a plus. * Expert knowledge in process characterization studies, PPQ, and commercialization ... rare disease indication. Responsibilities: *Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of… more
- PSC Biotech (York, PA)
- …variety of liquid injectables. BioTechnique utilizes our team's expertise to create a process design for our clients' products that best suits their needs. The ... completed and acceptable. Assure all issues/documentation associated with each process have been resolved and approved prior to progression,...site and QA staff. Serves as a Subject Matter Expert for internal or external matters. Acts as a… more
- Trilliant Food & Nutrition, LLC (Neenah, WI)
- …skills and creating good cross-functional relationships. Develop into a technical expert by developing new product formulations and improvements that fulfill ... trend research, documentation of specifications, evaluation of new products, process improvement, project management and supervision, and cost savings opportunities.… more
- Kindeva Drug Delivery/Summit Biosciences (Lexington, KY)
- …and execute validation activities-including equipment, utilities, facilities, and process validations-to ensure our operations remain compliant and inspection-ready. ... including plans, protocols, deviations, and final reports. Partner with Engineering , Manufacturing, Quality, and Regulatory Affairs to ensure effective… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The **Manager, Aseptic Process Engineer** leads the aseptic process validation program ... + Responsible for CTF Validation activities including, but not limited to Aseptic Process Simulations/ Validations (APS/APV) and Aseptic Performance… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …site expansion. OVERALL JOB RESPONSIBILITIES: Area Aseptic oversight: Subject matter expert for aseptic process , personnel technique for operations and ... state of audit readiness. This individual will be an aseptic subject matter expert and work with...Schedule, execute internal audits for assessment of review of aseptic technique, process assessment to determine proper… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …Round Lake aseptic fill/finish and Packaging facility, the Associate Director, Process Engineering will lead a cross-functional team responsible for the ... Manage and forecast capital and expense budgets related to process engineering activities and projects. + Guide...disruptions. ** Process and Packaging Oversight** + Provide expert -level technical guidance on aseptic filling processes,… more
- Lilly (Indianapolis, IN)
- …such as Equipment Preparation, Formulation, Filling, Freeze Drying, and Isolation systems, providing expert process engineering support globally. The ETC Sr. ... is responsible for providing global technical expertise in the engineering sciences related to Process Engineering...and overall customer service. The ETC Process Engineering team serve as technical resources in Aseptic… more
- Sanofi Group (Framingham, MA)
- …control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel ... **Job Title:** QC Expert - Microbiology **Location:** Framingham, MA **Hours:** Mon-Friday...the product during the difference stages of the manufacturing process . It aims to maintain a state of microbiological… more
- Lilly (Indianapolis, IN)
- …(GFD), development sites, as well as external manufacturing organizations and alliances. This Aseptic Process Engineering position serves as a technical ... as Equipment Preparation, Formulation, Filling, Freeze Drying, and Isolation systems, providing expert process engineering support globally. Parenteral sites… more
- Catalent Pharma Solutions (Harmans, MD)
- …data integrity. + Review and approve Protocols and Summary Reports for Process Validation such as PPQ's, Engineering studies, Cleaning Validation, etc. ... **Lead Specialist, QA Validation & Engineering ** Catalent Pharma Solutions is looking to hire...product. This position will provide continuous improvement support to process , equipment, utilities and computer systems and serve as… more
- Novo Nordisk (Clayton, NC)
- …Join Team Novo Nordisk and help us make what matters. The Position Serve as process subject matter expert (SME) for assigned production/ process area. Support ... different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot… more
- Lilly (Indianapolis, IN)
- …experience in chemical, materials, biomedical engineering or related fields. + Expert knowledge in parenteral filling process and handling of sterile ... Process Engineer in the area of parenteral filling process engineering to be a key contributor...herself through capability, efficiency, safety and continuous advancement in aseptic filling process and associated parenteral packaging… more
- Actalent (St. Louis, MO)
- …such as HPLC. Responsibilities include propagation of mammalian cell culture, aseptic cell culture operations, execution of large-scale production bioreactors, and ... and calibrators, completing batch records in compliance with cGMPs. + Perform in- process assays using equipment such as spectrophotometers, pH meters, and clinical… more
- Novo Nordisk (Clayton, NC)
- …(FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, ... the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the...based on the role.) Qualifications + Bachelor's degree in Engineering , Computer Science, or other relevant field from an… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- …As a **Senior Process Engineer** , you'll take ownership of the engineering lifecycle - from design to implementation to ongoing maintenance - across facilities, ... **Now Hiring: Senior Process Engineer - Pharmaceutical Manufacturing** **Location:** Onsite in...pharmaceutical environment? Join **PDS Tech** and help support complex engineering and CQV operations for one of the industry's… more
- Novo Nordisk (Clayton, NC)
- …Join Team Novo Nordisk and help us make what matters. The Position Serve as process subject matter expert (SME) for assigned CMO production/ process area. ... practices required + Good knowledge of overall practices for drug product manufacturing, aseptic filling process , quality management systems a plus + Proven… more
- Catalent Pharma Solutions (Baltimore, MD)
- …analysis, and presentation of the experimental results + Act as subject matter expert in Upstream Process Development of biologics including, but not limited ... **Job Title:** Sr. Manager Upstream Process Development **City:** Baltimore **State** : MD **JOB...drafting PFDs and reviews them. Provide technical support in engineering and GMPs runs + Lead and participate in… more
- Bristol Myers Squibb (Seattle, WA)
- …execute, and support experiments in the CTTO DP & Vector labs which includes aseptic processing and operation of automated process equipment. + Partner with ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Process Engineer in Cell Therapy Technical Operations (CTTO) will play a key… more
