Summary
We are seeking a Manufacturing Specialist to support manufacturing operations in a highly regulated environment. This role is responsible for providing technical support to manufacturing processes, leading investigations, supporting continuous improvement initiatives, ensuring compliance with GMP requirements, and collaborating with cross-functional teams to maintain operational excellence.
Responsibilities
- Provide day-to-day technical support to manufacturing operations.
- Monitor manufacturing processes and identify opportunities for operational improvements.
- Lead and support investigations related to process deviations, non-conformances, and manufacturing events.
- Perform root cause analyses and implement corrective and preventive actions (CAPAs).
- Collaborate with Manufacturing, Process Development, Quality, Engineering, and other cross-functional teams to resolve technical issues.
- Ensure compliance with GMP, GDP, safety, and quality requirements.
- Prepare, review, and maintain technical documentation, reports, investigations, and presentations.
- Analyze process data and manufacturing trends to support decision-making and process optimization.
- Support implementation of continuous improvement and Lean Manufacturing initiatives.
- Participate in risk assessments, change controls, and process monitoring activities.
- Assist in the development and revision of procedures, work instructions, and manufacturing documentation.
- Support audits, inspections, and regulatory compliance activities.
- Utilize manufacturing systems and digital tools to document, track, and monitor operational performance.
Qualifications
- Doctorate degree; OR Master's degree with 2+ years of Manufacturing Operations experience; OR Bachelor's degree with 4+ years of Manufacturing Operations experience; OR Associate degree with 8+ years of Manufacturing Operations experience; OR High School Diploma/GED with 10+ years of Manufacturing Operations experience.
- Educational background in Life Sciences, Biology, Chemistry, Engineering, or related disciplines.
- Experience in bioprocessing and manufacturing operations within a regulated environment.
- Knowledge of Root Cause Analysis methodologies including 5 Whys, Fishbone, Kepner-Tregoe, and similar problem-solving tools.
- Familiarity with Lean Manufacturing principles and continuous improvement practices.
- Strong knowledge of Good Documentation Practices (GDP) and GMP requirements.
- Experience working with systems and tools such as TrackWise, Veeva, MES, Smartsheet, Power BI, Spotfire, CDOCS, ChatGPT, Copilot, and process monitoring platforms.
- Strong technical writing, presentation, and communication skills in English and Spanish.
- Excellent analytical, organizational, and interpersonal skills.
- Ability to work independently, manage multiple priorities, and perform effectively under pressure.
- Team-oriented mindset with the flexibility to work extended hours when required.
Job Type: Full-time
Pay: $35.00 - $42.00 per hour
Education:
Experience:
- process monitoring : 5 years (Preferred)
- CDOCS: 5 years (Preferred)
- bioprocessing and manufacturing operations : 5 years (Preferred)
- Root Cause Analysis methodologies : 5 years (Required)
- 5 Whys: 5 years (Preferred)
- Fishbone: 5 years (Preferred)
- Kepner-Tregoe: 5 years (Preferred)
- Good Documentation Practices (GDP) : 5 years (Preferred)
- TrackWise, Veeva, MES, Smartsheet: 5 years (Preferred)
- Power BI, Spotfire, ChatGPT, Copilot: 5 years (Preferred)
Work Location: In person
