Deviation Management Specialist - I (Assistant)

Spectraforce Technologies, Inc.; West Point (PA); Presencial; USD 65.000 - 80.000; Jornada completa

Descripción de la vacante

Spectraforce Technologies, Inc. is seeking a Deviation Management Specialist - I (Assistant) to support West Point, PA operations.

The role focuses on resolving process deviations, implementing CAPAs, and providing technical support on the production floor within a cGMP pharmaceutical environment. The position requires 1–3 years post-bachelor experience, strong analytical skills, and proficiency in technical writing and cross-functional collaboration.

Formación

• B.S./M.S. in engineering or science field.
• 1–3 years post-bachelor experience in a cGMP pharma/biotech environment; academics acceptable.
• Experience writing investigations with root-cause analysis and CAPA development.
• Familiar with Lean Six Sigma methodologies.
• Strong written and verbal communication skills.
• Ability to work independently and in cross-functional teams.

Responsabilidades

• Resolve and reduce process deviations and lead investigations.
• Develop and implement corrective/preventive actions.
• Provide on-production floor technical support for manufacturing areas.
• Build relationships with counterparts in aseptic manufacturing, testing, planning, and release.
• Perform root cause analysis of lab/test failures and atypical events.
• Analyze complex problems and design lab/pilot scale experiments.

Conocimientos

Root cause analysis

CAPA development

Lean Six Sigma

Technical writing

Cross-functional teamwork

Analytical thinking

Educación

B.S./M.S. in engineering or science

Descripción del empleo

Deviation Management Specialist - I (Assistant)

West Point, PA 19486

12 months

Qualifications:

• B.S./M.S. degree in appropriate engineering/scientific field
• Minimum of 1-3 years post-Bachelor's degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry; Academic/internship experience accepted
• Previous experience in writing investigations with root cause analysis and corrective and preventative action (CAPA) development for atypical events in a manufacturing environment
• Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
• Demonstrated ability to work both independently and as a part of a cross‑functional team
• Excellent technical/scientific writing and verbal communication skills

Responsibilities:

• Primary responsibilities include resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
• This individual will be responsible for providing on production floor technical/scientific support for manufacturing areas within Manufacturing Division
• This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations
• Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required
• Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required.