Scientific Process Operator

Artech Information System LLC; Malvern (Chester County); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated manufacturing professional to join their dynamic team in a CGMP environment. This role is pivotal in executing manufacturing processes and ensuring compliance with industry standards. You will be responsible for maintaining high-quality documentation and adhering to safety protocols while working in a collaborative team setting. The ideal candidate will have a strong background in the biopharmaceutical sector, with a focus on SOPs and manufacturing execution systems. If you're passionate about contributing to innovative processes and thrive in a fast-paced environment, this opportunity is perfect for you.

Qualifications

• Degree in relevant field or equivalent experience in biopharmaceutical industry.
• Experience with SOPs and manufacturing processes is essential.

Responsibilities

• Execute manufacturing processes and maintain compliance with regulations.
• Document production parameters and analyze process data.

Skills

Manufacturing Execution System (MES)

Standard Operating Procedures (SOP's)

Mechanical aptitude

Process flow understanding

Routine and non-routine testing

Education

College degree

High School Diploma with +5 years experience

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

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:

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

ADDITIONAL RESPONSIBILITIES/DUTIES:

1. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA.
2. Adheres to the Safety Code of Conduct and attends all required EHS training.
3. Supports the ongoing production schedule by:
1. Reporting to work on-time and according to the shift schedule.
2. Being available for other duties as assigned.
3. Attending departmental and other scheduled meetings.
4. Demonstrating good interpersonal and communication skills.
5. Exhibiting a positive team-oriented attitude in the daily execution of procedures.
6. Promoting and working within a team environment.
7. Continuing professional development through learning new skills, procedures, processes and seminars.

Qualifications

Minimum Requirements:

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