Specialist III, Manufacturing Technical Operations
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Job Detail
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Offered Salary 0
Job Description
Qualifications
- Masters’ degree in a Scientific, Engineering or Biotech field with 6 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) OR
- Bachelor’s degree in a Scientific, Engineering or Biotech field with 8 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) OR
- Associate’s Degree or HS Diploma with 8-10 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- Knowledge of GMP’s, FDA regulations and documentation procedures, required
- Experience in quality systems regulations
- Previous experience in process deviation investigations and remediation, including major and/or critical deviations
- Previous experience authoring and/or revising technical documents
- Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget
- Excellent communication and technical writing skills
- Ability to support and/or lead system troubleshooting efforts
- Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
- Creative thinking with the ability to multi-task
- Commitment to ongoing professional development
- Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways
- On-site presence, as the role requires time on the manufacturing floor and cross-functional collaboration
- dynamic pace
Benefits
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Catalent offers rewarding opportunities to further your career!
Responsibilities
- As a Catalent employee, you will actively contribute to delivery of services to our clients and impact the well-being of their patients
- The Specialist III, MTO is responsible for the independent investigation, root cause determination, and development of appropriate corrective actions for deviations occurring during manufacturing operations at Catalent
- They will interact with multiple company functional groups (I.e., QA, Manufacturing, QC) as well as having direct interactions with client representatives
- This is a full time onsite role; 8am-5Monday – Friday
- Initiates Quality Records and conducts deviation investigations that meet both Industry and Catalent’s expectations
- Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
- Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective
- Leads or supports Continuous Improvement projects
- Conducts data gathering, trending, and data presentation as needed to support investigations
- Other duties as assigned
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Application ends in 13d 9h 1min