Specialist Manufacturing

hace 1 mes

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Summary:

The Manufacturing Operations Specialist will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role requires applying process, operational, and scientific expertise, basic compliance knowledge, and strong analytical and troubleshooting skills to enhance manufacturing operations. The candidate will also serve as the primary production process owner for process support systems and may assist with process ownership for more complex systems.

Key Responsibilities:

  • Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations. Serve as the document owner for these procedures.
  • Assess process performance through floor observation and performance data review. Implement solutions to improve processes.
  • Provide troubleshooting support for manufacturing processes.
  • Assist in the creation of training materials and conduct training on scientific or technical aspects of the manufacturing process.
  • Support the establishment of process monitoring parameters and control limits.
  • Collect and analyze process-monitoring data and assist in assessing deviations.
  • Ensure timely execution of quarterly process monitoring reports.
  • Ensure timely triaging of Non-conformances (NCs) within established goals.
  • Author investigation reports for NCs and execute corrective actions.
  • Manage NC and CAPA closure within established timelines and communicate incident trends.
  • Review equipment/system Root Cause Analysis (RCA) investigations and support trend evaluations.
  • Assist in generating process validation protocols and reports.
  • Support the execution of process validations and the collection/analysis of validation data.
  • May participate in regulatory inspections as required.
  • Participate in NPI processes to assess documentation, material, training, and equipment modification requirements.
  • Provide project management support for implementing process or equipment modifications.
  • Assist manufacturing change owners in managing CCRB packages impacting manufacturing processes.
  • Manage change control records for process-related changes.
  • Contribute to the assessment or implementation of special projects or initiatives.
  • Perform other duties as assigned.

Skills & Competencies:

  • In-depth technical knowledge of bioprocessing unit operations.
  • Experience in GMP production operations and regulatory compliance.
  • Strong ability to participate in and lead cross-functional teams.
  • Excellent communication and collaboration skills with technical and management staff across manufacturing, process development, and quality.
  • Strong organizational, technical writing, and presentation skills.
  • Basic project management capabilities.
  • Understanding of control charting and process monitoring.

Requirements

Qualifications:

  • Doctorate degree, or
  • Master’s degree with 3 years of Manufacturing Operations experience, or
  • Bachelor’s degree with 5 years of Manufacturing Operations experience, or
  • Associate’s degree with 10 years of Manufacturing Operations experience, or
  • High school diploma/GED with 12 years of Manufacturing Operations experience.

Preferred Qualifications:

  • Experience with Change Control, CAPA, VAPA EV, deviations, and documentation handling will make a candidate stand out.

Work Schedule:

  • 8-hour shift, 8:00 AM to 5:00 PM, flexible to work weekends.

  • Manufacturing Specialist

    hace 1 mes

    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job SummaryIntegrated Services For Productivity & Validation, Inc is seeking a highly skilled Manufacturing Specialist to support the execution of manufacturing/quality systems. The ideal candidate will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing...

  • Manufacturing Process Specialist

    hace 3 semanas

    Juncos, Puerto Rico Msss, Inc. A tiempo completo

    Job Description:We are seeking a highly skilled Manufacturing Process Specialist to join our team at Msss, Inc.About the Role:The ideal candidate will have experience in manufacturing processes and be able to perform hands-on operations, set-up, clean, sanitize, and prepare media and buffers per procedures.Key Responsibilities:

  • Manufacturing Operations Specialist

    hace 4 semanas

    Juncos, Puerto Rico Inteldot A tiempo completo

    Job DescriptionInteldot, a leading life science company with operations across Puerto Rico, the United States, Europe, and Japan, is seeking an experienced Manufacturing Operations Specialist to support its manufacturing/quality systems.About InteldotWith over 14 years of experience in the life science industry, Inteldot has established itself as a trusted...

  • Manufacturing Operations Specialist

    hace 2 meses

    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job RequirementsIntegrated Services For Productivity & Validation, Inc is seeking a skilled Manufacturing Operations Specialist with expertise in facilities change control and process management.Key responsibilities include:Managing facilities change control processes to ensure effective decommissioningUtilizing Trackwise and Veeva to streamline operations...

  • Manufacturing Operations Specialist

    hace 1 mes

    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job DescriptionWe are seeking an experienced Manufacturing Operations Specialist to join our team at Integrated Services For Productivity & Validation, Inc. As a key member of our organization, you will be responsible for managing facilities change control and ensuring seamless operations.The ideal candidate will have expertise in decommissioning processes...

  • Manufacturing Process Audit Specialist

    hace 2 días

    Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    We are seeking a Manufacturing Process Audit Specialist to join the QRC Group LLC team. The ideal candidate will have experience in manufacturing process audits, batch record reviews, and knowledge of DAI processes, PASx/MES applications, MAXIMO, SAP, and LIMS.Additionally, the successful candidate must be available for non-standard shifts, including nights...

  • Manufacturing Specialist

    hace 1 mes

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    Kelly Science & Clinical is seeking a Manufacturing Specialist near Juncos, PR. 6 month contract Shift: Monday - Friday 8am-5pm, needs to be flexibleCompensation: $38/hr SUMMARYWe are seeking a dynamic and detail-oriented Manufacturing/Quality Systems Specialist to join our team. With minimal supervision, you will support the execution of various...

  • Manufacturing Operations Specialist

    hace 3 semanas

    Juncos, Puerto Rico Quality Consulting Group A tiempo completo

    About UsQUALITY CONSULTING GROUP, a leading pharmaceutical and biotech company, is seeking a highly skilled Manufacturing Operations Specialist to join our team.We are a world-class manufacturer in Puerto Rico & USA, dedicated to delivering high-quality products and services. Our team members are passionate about what they do and strive for excellence in...

  • Manufacturing Process Specialist

    hace 1 mes

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    Job DescriptionKelly Services, Inc. is seeking a skilled Manufacturing Process Specialist to join our team in Juncos, PR.About the JobWe offer a competitive salary of $38 per hour for this 6-month contract position.Key Responsibilities:Support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures,...

  • Manufacturing Process Specialist

    hace 2 meses

    Juncos, Puerto Rico Mirus Consulting Group A tiempo completo

    Job SummaryMirus Consulting Group is a leading provider of computer system validation and information technology consulting services to pharmaceutical companies and other organizations. We are seeking a highly skilled Manufacturing Process Specialist to support the execution of manufacturing/quality systems.Key ResponsibilitiesSupport the assessment and...

  • Manufacturing Operations Specialist

    hace 1 mes

    Juncos, Puerto Rico Pharmalex A tiempo completo

    About UsPharmaLex is a leading consulting company in the Healthcare industry, providing expert services globally. We foster professional growth and development, along with a collaborative work environment that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.Job OverviewWe are seeking an experienced Manufacturing Operations...

  • Manufacturing Operations Specialist

    hace 4 semanas

    Juncos, Puerto Rico Mirus Consulting Group A tiempo completo

    Mirus Consulting Group, a local company based in Puerto Rico, is seeking a Manufacturing Operations Specialist to support the execution of manufacturing/quality systems.As a key member of our team, you will apply process, operational, scientific expertise, and analytical skills to support manufacturing operations. You may serve as primary production process...

  • Manufacturing Process Specialist

    hace 1 mes

    Juncos, Puerto Rico Quality Consulting Group A tiempo completo

    Quality Consulting Group is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. We are seeking a highly motivated and enthusiastic Manufacturing Process Specialist to contribute to our world-class manufacturing operations in Puerto Rico & USA.About the Role:This role involves supporting the execution of manufacturing/quality...

  • Manufacturing Process Specialist

    hace 3 semanas

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    Company OverviewKelly Services, Inc. is a leading provider of talent solutions, connecting professionals with premier scientific and clinical companies.Salary: $38 per hourJob DescriptionWe are seeking a dynamic and detail-oriented Manufacturing/Quality Systems Specialist to join our team in Juncos, PR. The successful candidate will support the execution of...

  • Manufacturing Operations Specialist

    hace 1 mes

    Juncos, Puerto Rico Msss, Inc. A tiempo completo

    We are seeking a skilled Manufacturing Operations Specialist to join our team at Msss, Inc. in the United States.Salary: $55,000 - $65,000 per year.Job Description:In this role, you will manufacture products according to established Standard Operating Procedures under general supervision.You will perform hands-on operations, set-up, and cleaning per...

  • Manufacturing Operations Specialist

    hace 4 semanas

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    Job Summary:We are seeking a skilled Manufacturing Operations Specialist to join our team at Kelly Services, Inc. near Juncos, PR. This is a 6-month contract opportunity with competitive compensation of $38/hour.About the Role:This dynamic position requires minimal supervision and involves supporting various manufacturing and quality systems including...

  • Manufacturing Operations Specialist

    hace 1 mes

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    About the Role:">We are seeking an experienced Manufacturing Operations Specialist to join our team at Kelly Services, Inc."Job Summary:">This is a fantastic opportunity to work in a dynamic environment where you will be responsible for performing and monitoring critical processes, executing routine validation protocols, and drafting and revising routine...

  • Manufacturing Operations Specialist

    hace 4 semanas

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    At Kelly Services, Inc., we're passionate about helping you find a job that fits your skills and experience. We're seeking a Manufacturing Operations Specialist to join our team in the east region of Puerto Rico.This role might be an excellent fit if you have:A bachelor's degree in a science-related field.Experience with manufacturing processes, including...

  • Manufacturing Operations Specialist

    hace 4 semanas

    Juncos, Puerto Rico Pharmalex A tiempo completo

    Are you a seasoned operations expert looking for a new challenge? We have an exciting opportunity at Pharmalex, a leading consulting company in the Healthcare industry. In this role as Manufacturing Operations Specialist, you will play a key part in ensuring the smooth execution of manufacturing/quality systems.Responsibilities:Process Monitoring: Establish...

  • Manufacturing Operations Engineer

    hace 2 días

    Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Job SummaryWe are seeking a highly skilled Manufacturing Operations Engineer with expertise in equipment start-up, troubleshooting, and control systems. As an Equipment Specialist, you will provide solutions to technical problems of moderate scope and complexity.