Manufacturing Technician — cGMP/GLP, First Shift

Actalent; Woburn (MA); On-site; USD 34,000 - 49,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Short and long-term disability

Health Spending Account (HSA)

Job summary

Actalent is seeking a Manufacturing Technician for a contract position in Woburn, MA. The role focuses on cGMP manufacturing in a regulated setting, operating automated equipment, and maintaining GDP-compliant documentation.

You will support root cause analyses, investigations, and related R&D activities, while assisting with quality control tasks. The work is onsite in a GLP-compliant startup environment with strong funding and expanding products.

Qualifications

• Experience performing cGMP manufacturing operations in a regulated environment.
• Ability to operate automated manufacturing equipment and record in-process data accurately.
• Proficiency in completing production and testing records following GDP.
• Knowledge of SOP, GMP, and GDP requirements.
• Experience contributing to root cause analyses and manufacturing investigations.
• Familiarity with batch records and documenting batch record activities.
• Background in biology, pharmaceutical manufacturing, or medical device manufacturing.
• Ability to work effectively in a team and communicate clearly.
• Associate degree in a life science or 2+ years of biopharmaceutical GMP experience.

Responsibilities

• Perform cGMP manufacturing operations in accordance with documented procedures and batch records.
• Operate automated manufacturing equipment safely and efficiently while adhering to procedures.
• Record in-process data in real time to ensure complete production records.
• Complete production and testing records following GDP to maintain data integrity.
• Follow SOP, cGMP, and GDP requirements in daily activities.
• Contribute to root cause failure analyses and manufacturing investigations.
• Investigate deviations, nonconformances, and process issues; support CAPAs.
• Support manufacturing-related R&D activities, including process optimization.
• Assist with quality control tasks, including sample handling and coordination with QC.
• Collaborate with team to maintain a safe, compliant, and efficient environment.

Skills

cGMP manufacturing

Automated equipment operation

GDP documentation

SOP/GMP/GDP compliance

Root cause analysis support

Batch records/documentation

Team collaboration

Biopharmaceutical manufacturing

Communication

Education

Associate degree in life sciences

Job description

Actalent is seeking a Manufacturing Technician for a contract position in Woburn, MA. The role focuses on cGMP manufacturing in a regulated setting, operating automated equipment, and maintaining GDP-compliant documentation.

You will support root cause analyses, investigations, and related R&D activities, while assisting with quality control tasks. The work is onsite in a GLP-compliant startup environment with strong funding and expanding products.