- Regeneron Pharmaceuticals (East Greenbush, NY)
- …newly constructed Fill Finish facility; a background in equipment validation, project/ process engineering and/or Facility Commissioning is helpful + **Equipment ... metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (eg Equipment...gloves and the use of sanitizing agents during gowning process including IPA) + Ability to remove jewelry, make-up… more
- Chobani (Twin Falls, ID)
- …customer focused individual with a wide array of programming and controls engineering skills. The individual also must be a highly effective troubleshooter as ... related issues. Serve as automation and controls subject matter expert on local project teams. Serve as a high...packaging, rotary fillers and blow molders a plus Electrical Engineering degree and/or 10+ years of experience preferred. Advanced… more
- Novo Nordisk (Bloomington, IN)
- …Join Team Novo Nordisk and help us make what matters. As a Senior Aseptic Manufacturing Process Engineer at Novo Nordisk, you will leverage your extensive ... best practices. You will act as a subject matter expert for aseptic processes and mentor junior...Process Development activities. + Apply comprehensive knowledge of engineering principles and concepts to support experimental and project… 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
- Novo Nordisk (Bloomington, IN)
- …your potential? Join Team Novo Nordisk and help us make what matters. As an Aseptic Manufacturing Process Engineer at Novo Nordisk, you will play a pivotal role ... is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product… 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
- Merck (Durham, NC)
- …API Manufacturing, cGMP Regulations, Change Control Systems, Chemical Engineering , Chemical Process Development, Cross-Cultural Awareness, Cross-Functional ... and presenting to auditors as needed. + Act as a validation subject matter expert in support of quality risk assessments and regulatory inspections. + Partner with… more
- Merck (West Point, PA)
- …operation and improvement of a vaccine manufacturing facility with a focus on process engineering . **Responsibilities may include:** + Serves as the subject ... matter expert (SME) for a liquid vaccine manufacturing ...Process Improvements, Manufacturing Process Validation, Mechanical Engineering , Mechatronics, Process Engineering , … more
- Merck (Durham, NC)
- …excellent opportunity for highly trained individuals with expertise working in aseptic production and manufacturing operations. The individual in this position will ... support the Vaccine manufacturing process through hands on processing activities. Key responsibilities for the Senior Production Technician include the execution of … more
- WuXi AppTec (Philadelphia, PA)
- …to current Good Manufacturing Practices (cGMPs). **Responsibilities** + Understands aseptic technique concepts + Oversees and monitors overall performance of ... technique ensuring compliance with standards + Has performed aseptic technique, is able to identify unacceptable practices and...cell and gene therapy + Possesses basic and fundamental engineering and mechanical knowledge and is able to apply… 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
- Lilly (Indianapolis, IN)
- …the safe design and safe operation of the equipment within the area. + Provide engineering expertise as active member of area process team. + Obtain technical ... requests related to the equipment. + Communicate effectively with others, especially process team members, operations, engineering tech, and crafts personnel. +… more
- WuXi AppTec (Philadelphia, PA)
- …according to current Good Manufacturing Practices (cGMPs). **Responsibilities** * Understands aseptic technique concepts * Has performed aseptic technique, is ... is able to explain 'why' of acceptable and unacceptable aseptic technique practices * Trains others on basic ...pharmaceutical and biotechnology industry * Possesses basic and fundamental engineering and mechanical knowledge and is able to apply… 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
- BeOne Medicines (Pennington, NJ)
- …automated inspection machines. + Expert level knowledge in IQ/OQ/PQ and process engineering + Expertise in late stage/commercial Drug Product technology ... / Control Systems + Deviation Assessments / Investigations + SAP, LIMS, CMMS, Veeva + Expert level knowledge in all Drug Product aseptic filling operation + … more
- ThermoFisher Scientific (Plainville, MA)
- …and evenings, as the need arises to meet project timelines. **Upstream Process Development Qualifications:** + Practical experience in aseptic techniques, cell ... a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, we offer the expertise...manufacturing. You will also act as a subject matter expert (SME) and support transfer and operation of internally… more
- Novo Nordisk (Clayton, NC)
- …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 ... aseptic "fill and finish" site that is responsible for...help us make what matters. The Position Primary technical expert supporting the leader in making recommendations and delivering… more
- Actalent (St. Louis, MO)
- …purification and filtration/HPLC, including propagation of mammalian cell culture, aseptic cell culture operations, execution of large-scale production bioreactors, ... controls and calibrators and complete batch records following cGMPs. + Perform in- process assays using equipment such as spectrophotometers, pH meters, and clinical… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …the facility is accurately staffed and trained and supporting a production planning process that is multifaceted and flexible to meet the needs of Regeneron's ... effectively across IOPS departments, such as Quality Assurance, Facilities, Engineering , External Manufacturing, MSAT, Regulatory, Quality Control, IT and Supply… more