Associate Manufacturing

Responsibilities

• Perform 100% manual inspection
• Perform post manual inspection packaging operations
• Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures
• Understand process parameters and can identify process anomalies
• Operate critical processing equipment
• Aid and implement continuous improvement solutions related to routine functions
• Absorb and implement changes to manufacturing schedules
• Supports resource needs for processing operations on the manufacturing floor
• Identify and propose solutions to complex problems
• Responsible for identifying and communicating problems during operations
• Performs initial review of manufacturing procedures/batch records
• Reviews, revises, and audits documents
• Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
• Provides hands-on training to others
• Provides suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
• Applies research, information gathering, analytical and interpretation skills to problems of diverse scopes
• Utilizes basic project management skills to set project timelines and priorities-based project objectives and ongoing assignments
• Recognizes and escalates problems
• Able to establish working relationships with others outside area of expertise
• Able to support flexible shift structure in support of operations (may include off-shift and weekends)
• Able to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position
• Organizational skills and an ability to perform assignments with a high degree of attention to detail
• Written and oral communication skills. Technical writing capability
• GMP knowledge with ability to interpret and apply applicable regulations
• Able to understand processing methods for manufacturing area

Requirements

• High school/GED + 2 years biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) work experience OR
• Associates + 6 months biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) work experience OR
• Bachelors
• Experience with manual visual inspection in a GMP regulated environment
• Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
• Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
• Demonstrated technical writing capability
• Knowledgeable of manual visual inspection background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
• Demonstrated ability to work in a team

Qualifications

• High school/GED + 2 years biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) work experience OR
• Associates + 6 months biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) work experience OR
• Bachelors