Manufacturing Process Specialist

2 months ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary

We are seeking a highly skilled and experienced Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will be responsible for supporting the formulation manufacturing process, ensuring quality and efficiency, and providing technical expertise to drive process improvements.

Key Responsibilities
  • Support the formulation manufacturing process, ensuring quality and efficiency
  • Provide technical expertise to drive process improvements, including the development and implementation of new processes and technologies
  • Conduct real-time monitoring and trending of manufacturing processes and finished product analytical data
  • Develop and maintain databases to provide trending capability for process parameters
  • Develop and maintain production metrics through the use of analytical tools
  • Conduct frequent and thorough periodic reviews of database and trends, identifying opportunities for improvement in performance, manpower effectiveness, and efficiency
  • Actively identify unfavorable trends and investigate root cause, implementing effective preventive actions
  • Provide leadership and manufacturing support in investigations, as assigned
  • Assure the resolution of deviations, corrective actions, Change Control action items, and any audit non-compliance items
  • Ensure the timely completion of assigned deviations and CAPAs
  • Perform process and equipment evaluation (FMEA, etc.) to identify risks and weaknesses in new and current processes
  • Write, revise, develop, and implement SOPs and other GMP documentation in support of new or changed manufacturing processes, in cooperation with appropriate manufacturing personnel
  • Establish familiarity with all manufacturing activities involved in the sterile production process to share best practices and streamline operations
  • Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades
  • Act as a manufacturing liaison in project planning and coordination
  • Represent manufacturing on process design teams
  • Champion projects as they move into and through the manufacturing areas
  • Author, drive, and assure accurate and timely execution of process Change Controls; Partner with other bulk groups, when necessary
  • Provide regular updates to manufacturing management on the status and issues involved in projects
  • Perform troubleshooting of issues and non-conformance items
  • Provide administrative support to manufacturing in authoring and reviewing engineering/validation documentation, as assigned
  • Support manufacturing management in periodic review of existing and new revisions to manufacturing documentation, in regards to (but not limited to): Operability, Technical accuracy, Compliance, and Process Robustness
  • Support production of pharmaceutical formulations
  • Maintain individual training proficiency; Train operators on processes
  • Document all work as required by cGMPs on a timely basis
  • Abide by all safety requirements as defined by the company
  • Assist with RCRA and safety inspections, as required
  • Other tasks as assigned by management
Requirements
  • BS Degree or equivalent experience
  • 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting
  • Preferred Experience: BS Degree in Engineering, Chemistry, or Biology
  • Experienced working on (and coordination of) multiple projects in an orderly and efficient manner, while consistently meeting established deadlines
  • Experienced in working successfully across departments to meet company objectives
  • Ability to lift/move 50lbs. overhead; Ability to team-lift 100 lbs.
  • Ability to operate all types of production equipment
  • Ability to self-manage and prioritize work load
  • Ability to gown properly for clean room operations
  • Ability to read, understand, and follow company SOPs and guidelines
  • Ability to stand or sit for extended periods of time (up to 2 hours at a time)
  • Strong knowledge of pharmaceutical manufacturing processes
  • Working knowledge of Good Manufacturing Practices (US and EU)
  • Ability to quickly understand detailed and complex processes
  • Computer proficiency with JMP, Microsoft Word, Excel, PowerPoint
  • Must be able to work in office and manufacturing environment
  • Some travel required (< 10%)
Personal Attributes
  • Dependable, well-organized, efficient
  • Detail and results-oriented
  • Motivated self-starter; Willing to learn new tasks, skills
  • Works well in a team environment
  • Strong oral and written communication skills
  • Responds quickly to assignments; Readily adapts to changing job duties
  • Manages time well; Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines
  • Ability to work cross-functionally to meet company objectives
  • Positive attitude; Displays understanding of and promotes company objectives

  • Manufacturing Process Specialist

    2 weeks ago

    Wilmington, Delaware, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will be responsible for supporting the Vivitrol formulation manufacturing process, ensuring quality and efficiency, and providing technical expertise to development and engineering...

  • Manufacturing Process Specialist

    2 months ago

    Wilmington, Delaware, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will play a critical role in supporting the Vivitrol formulation manufacturing process.Key ResponsibilitiesSupport on-going manufacturing efforts in terms of quality and efficiencyInterface with...

  • Manufacturing Process Specialist

    4 weeks ago

    Wilmington, Delaware, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will be responsible for supporting the Vivitrol formulation manufacturing process, ensuring quality and efficiency, and providing technical expertise to development and engineering teams.Key...

  • Manufacturing Process Specialist

    1 month ago

    Wilmington, Delaware, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will be responsible for supporting the Vivitrol formulation manufacturing process, ensuring quality and efficiency, and providing technical expertise to development and engineering teams.Key...

  • Manufacturing Process Specialist

    6 days ago

    Wilmington, Delaware, United States Engineer Rec Full time

    Process Engineer OpportunityWe are seeking a skilled Process Engineer to join our team in North Carolina. As a Process Engineer, you will be responsible for supporting different teams throughout the organisation, identifying and understanding manufacturing and production processes, and implementing changes to reduce costs and increase efficiency.Key...

  • Manufacturing Engineer

    2 weeks ago

    Wilmington, Delaware, United States Biotechnology Manufacturing Full time

    Job Title: Mechanical Manufacturing EngineerOur client, a leading Biotechnology Manufacturing firm, is seeking a skilled Mechanical Manufacturing Engineer to join their team in Wilmington, Delaware.Key Responsibilities:Provide mechanical design and troubleshooting support to address production challenges.Manage vendor quality by conducting assessments and...

  • Manufacturing Systems Engineer

    1 month ago

    Wilmington, Delaware, United States Biotechnology Manufacturing Company Full time

    Biotechnology Manufacturing EngineerOur client, a leading Biotechnology firm, is seeking a Biotechnology Manufacturing Engineer to join their team in Wilmington, Delaware. The successful candidate will be responsible for providing essential production support through controls troubleshooting and design, the conception and implementation of new production...

  • Manufacturing Process Engineer

    4 weeks ago

    Wilmington, Delaware, United States Agilent Full time

    Job Title: Manufacturing Process EngineerThis is an exciting opportunity to lead the design and implementation of complex manufacturing processes at Agilent Technologies, Inc.Key Responsibilities:Lead the day-to-day manufacturing operations of an advanced thin film deposition facility.Utilize materials characterization and analytical techniques for thin film...

  • Manufacturing Process Engineer

    4 weeks ago

    Wilmington, Delaware, United States Agilent Full time

    Job DescriptionThis position offers an opportunity to lead in the design and implementation of complex manufacturing processes, transforming broad concepts into structured, results-focused projects. The role involves improving products, processes, and components to meet objectives, supporting new product introductions, managing the transition of products...

  • Manufacturing Process Engineer

    2 weeks ago

    Wilmington, Delaware, United States Mastech Digital Full time

    Job OpportunityMastech Digital is seeking a skilled Process Engineer-Manufacturing to join our team in the Manufacturing domain. As a Process Engineer-Manufacturing, you will play a key role in driving process improvements, creating work instructions, and solving complex problems.Key Responsibilities:Develop and implement process improvements to increase...

  • Manufacturing Process Engineer

    2 weeks ago

    Wilmington, Delaware, United States Agilent Technologies Full time

    Job SummaryThis is an exciting opportunity to lead the design and implementation of complex manufacturing processes at Agilent Technologies. As a Manufacturing Process Engineer, you will be responsible for transforming broad concepts into structured, results-focused projects.Key ResponsibilitiesLead the day-to-day manufacturing operations of an advanced thin...

  • Manufacturing Process Engineer

    2 weeks ago

    Wilmington, Delaware, United States Agilent Full time

    Job SummaryThis is an exciting opportunity to lead the design and implementation of complex manufacturing processes at Agilent Technologies. As a Manufacturing Process Engineer, you will be responsible for transforming broad concepts into structured, results-focused projects. Your expertise will be crucial in improving products, processes, and components to...

  • Mechanical Engineer

    4 weeks ago

    Wilmington, Delaware, United States Biotechnology Manufacturing Full time

    Job Title: Mechanical EngineerWe are seeking a skilled Mechanical Engineer to join our Biotechnology Manufacturing team in Wilmington, Delaware. As a Mechanical Engineer, you will play a critical role in supporting production challenges, managing vendor quality, and developing mechanical reliability plans.Key Responsibilities:Provide mechanical design and...

  • Manufacturing Process Engineer

    1 month ago

    Wilmington, Delaware, United States Agilent Technologies Full time

    Job DescriptionThis position offers an opportunity to lead in the design and implementation of complex manufacturing processes, transforming broad concepts into structured, results-focused projects.The role involves improving products, processes, and components to meet objectives, supporting new product introductions, managing the transition of products from...

  • Manufacturing Process Engineer

    2 weeks ago

    Wilmington, Delaware, United States Mastech Digital Full time

    {"title": "Manufacturing Process Engineer Position", "company": "Mastech Digital", "description": "We are seeking a skilled Manufacturing Process Engineer to join our team. The ideal candidate will have 8+ years of experience in process engineering, preferably in aerospace or defense industries. The successful candidate will have a strong understanding of...

  • Process Inspector

    2 weeks ago

    Wilmington, Delaware, United States Innova Solutions Full time

    Job Title: Process Inspector - ManufacturingA leading company in the industry is seeking a skilled Process Inspector to join their team. As a Process Inspector, you will be responsible for ensuring the quality of manufactured products by conducting thorough inspections and analyzing measurement results.Key Responsibilities:Analyze measurement results and...

  • Manufacturing Process Improvement Engineer

    5 days ago

    Wilmington, Delaware, United States Corning Incorporated Full time

    Job Summary:A Manufacturing Process Improvement Engineer at Corning Incorporated will monitor and improve established manufacturing processes and equipment. This role requires leveraging fundamental understanding of manufacturing, data retrieval and analysis techniques, rigorous problem-solving methodologies, and scientific methods.Key Responsibilities:Work...

  • Manufacturing Project Specialist

    2 months ago

    Wilmington, Delaware, United States TS Tech Full time

    Position Title: Manufacturing Project SpecialistCompany: TS TechRequired Qualifications:Comprehensive knowledge of operational and engineering methodologies within a Just-In-Time (JIT) production setting.Exceptional written, verbal, organizational, interpersonal, and leadership capabilities.Prior experience in manufacturing or engineering roles is...

  • Manufacturing Process Optimization Engineer

    7 days ago

    Wilmington, Delaware, United States Blue Bird Full time

    Job Summary:We are seeking a skilled Manufacturing Process Optimization Engineer to join our Production Engineering Team at Blue Bird. This role will be responsible for delivering activities related to optimizing production manufacturing processes through developing, planning, and implementing improvements that positively impact Safety, Quality, Labor, and...

  • Manufacturing Engineer

    2 weeks ago

    Wilmington, Delaware, United States Textron Full time

    About This RoleWe are seeking a highly skilled Manufacturing Engineer to join our team at Textron Systems. As a key member of our manufacturing team, you will be responsible for developing and improving manufacturing processes, procedures, and production layouts for the fabrication and assembly of detail parts and end item products.Key...