Scientific Process Operator

LanceSoft Inc; Malvern (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company in Chester County is seeking a skilled professional for a crucial role in executing manufacturing procedures within a cGMP environment. The ideal candidate will have a college degree or HS diploma along with over 5 years of experience in the biopharmaceutical industry, focusing on quality compliance and team-oriented tasks. Responsibilities include executing processes according to standard operating procedures, verifying production parameters, and maintaining documentation accuracy. This role offers opportunities for professional development and teamwork.

Qualifications

• Experience in the biopharmaceutical industry is required.
• Knowledge of cGMP standards.
• Ability to follow SOPs with 100% adherence.

Responsibilities

• Execute manufacturing processes according to SOPs.
• Analyze trend charts and process data.
• Complete documentation in GMP forms.

Skills

Interpersonal skills

Team-oriented attitude

Problem-solving

Attention to detail

Education

College degree or HS Diploma with +5 years biopharmaceutical experience

Tools

MS Office

SAP Production

Job description

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Operations Services 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 analyze 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

*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

ESSENTIAL FUNCTIONS PER JOB LEVEL:

Autonomy and Complexity

Basic Technical Knowledge within functional area

Introduced to troubleshooting of routine manufacturing processes

Needs direction to perform daily tasks

May offer suggestions for process improvements

Good understanding of cGMP

Attend PE awareness classes and may participate PE projects

COMPUTER ABILITY:

Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required

Ability to learn and operate a range of industry systems including SAP Production, Werum MES, Compliance-Kaplan Wire and others

LANGUAGE SKILLS:

Read and interpret documents such as safety rules, operating instructions and logbooks

Review and provide feedback for SOP and Batch Record revisions.

REASONING ABILITY:

Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Follows both verbal and written instructions (100% adherence to SOPs)

Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists

Work with high level of concentration

Accept and adapt to procedural changes

Qualifications

EDUCATION and/or EXPERIENCE:

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 MES would be an advantage

Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment would be an advantage

Additional Information

College degree or HS Diploma with +5 years biopharmaceutical industry experience