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Deviation Management Specialist
2 months ago
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- Job Description
Deviation Management Specialist
Contract: West Point, Pennsylvania, US
Salary: $41.00 Per Hour
Job Code: 355073
End Date: 2024-11-17
Days Left: 28 days, 3 hours left
Apply
About the Role:
- We are seeking a qualified candidate to join our team as a Technical
- Services Engineer in the pharmaceutical/biotech industry.
- The individual will be responsible for providing technical support to manufacturing operations, investigating process deviations, and implementing corrective/preventative actions.
- This role requires a strong background in mechanical or chemical engineering, as well as experience in a cGMP environment.
Responsibilities:
- Provide day-to-day technical support to manufacturing operations -
- Resolve and reduce process deviations
- Develop and implement corrective/preventative actions
- Lead manufacturing and laboratory investigations
- Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release
- Utilize scientific and engineering principles to investigate process deviations
- Conduct real-time troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events
- Analyze complex problems through critical analytical thinking and design/execution of experiments
- Off-shift work may be required
Education Qualification:
- B.S./M.S. in Mechanical or Chemical Engineering degree or other science degree
Required Skills:
- 0-3+ years of relevant work experience in a cGMP environment in pharmaceutical/biotech industry
- Support of vaccine operations or technical services support
- Experience in writing investigations for atypical events in a manufacturing environment
- Experience with troubleshooting biotech equipment, barrier technology, and closed system processing
- Familiarity with MEDS, SAP
- Ability to read Piping and Instrumentation Diagrams
- Knowledge of Lean Six Sigma Methodologies
- Proven analytical and problem-solving capabilities
- Ability to work independently and as part of a cross-functional team
- Excellent written and verbal communication skills
Note:
- Top skillsets include previous deviation management experience, root cause analysis experience, time management, and investigation writing experience.
- Candidates may be asked for writing samples during interviews.
- A cool, calm, collected personality is preferred.
- Backgrounds in chemical engineering or science are suggested.
- The typical day involves huddle meetings, error reviews, investigations, research, and writing tasks.
Job Requirement
- pharmaceutical
- deviation
- chemical engineering
- troubleshooting
- root cause analysis
- investigations
- CAPA
- cGMP
- GMP
- Deviation
- Deviation management
- Recruiter
- Phone
- Rohan Lazarus
- rohan.lazarus@collabera.com
Apply Now
