Scientific Process Operator

Artech Information System LLC; Malvern (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

A biopharmaceutical company is seeking an individual responsible for manufacturing procedures and maintaining compliance in a CGMP environment. The role involves executing processes per Standard Operating Procedures, ensuring documentation accuracy, and demonstrating a commitment to safety and teamwork. Candidates must possess a college degree or HS diploma along with 5+ years of relevant experience in the biopharmaceutical industry, ideally with a background in Manufacturing Execution Systems. Strong communication and mechanical aptitude are preferred.

Qualifications

• 5+ years of experience in the biopharmaceutical industry.
• Experience with Standard Operating Procedures (SOPs).
• Knowledge of testing and sampling methods.

Responsibilities

• Execute manufacturing processes according to standards.
• Complete documentation accurately in SOPs and logbooks.
• Maintain compliance with safety regulations.
• Support ongoing production schedules.

Skills

Manufacturing Execution System (MES)

Mechanical aptitude

Process flow understanding

Interpersonal skills

Communication skills

Education

College degree or HS Diploma with 5+ years experience

Job description

Job Description

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Upstream group. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.

ESSENTIAL FUNCTIONS:

• Executes manufacturing processes according to Technical Operations and Operational Services standard operating procedures
• Verifies and enters production parameters per SOP and Batch Record on trained procedures
• Retrieves and analyzes trend charts and process data on trained procedures
• Accurately completes documentation in SOP's, logbooks and other GMP documents
• Demonstrate training progression through assigned curriculum
• Accountable for adherence to compliance policies and regulations
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments
• Takes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

ADDITIONAL RESPONSIBILITIES/DUTIES:

• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA.
• Adheres to the Safety Code of Conduct and attend all required EHS training
• Support the ongoing production schedule by:
• Report to work on-time and according to the shift schedule
• Be available for other duties as assigned
• Attend departmental and other scheduled meetings
• Good interpersonal and communication skills
• Demonstrates positive team-oriented attitude in the daily execution of procedures
• Promote and work within a team environment
• Continue professional development through learning new skills, procedures, processes and seminars

Qualifications

• College degree or HS Diploma with +5 years biopharmaceutical industry experience
• Experience must be Biotech/Pharmaceutical industry or relevant experience working with Standard Operating Procedures (SOP's) where formal documentation is required
• Previous experience with Manufacturing Execution System (MES) would be an advantage
• Mechanical aptitude for assembling and disassembling process equipment would be an advantage
• Process flow aptitude to recognize and understand process pathways
• Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment would be an advantage