Manufacturing Technician

SmartRecruiters, Inc.; Malvern (Chester County); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Group medical insurance with dental &视

Dental coverage

Vision coverage

Job summary

SmartRecruiters, Inc. is seeking a Temporary Biotechnician (Scientific Process Operator) in Malvern, PA, for a 06-month contract with potential extension up to 24 months.

The role reports to Manufacturing Supervisor in Technical Operations and focuses on CGMP downstream manufacturing processes. Responsibilities include executing manufacturing procedures, documenting parameters, analyzing process data, and maintaining high compliance with SOPs, batch records and safety regulations.

Qualifications

• College degree or HS Diploma with ≥5 years industrial experience.
• Biotech/Pharmaceutical industry background or SOP documentation experience preferred.
• Experience with SOPs, batch records and GMP documentation advantageous.
• Knowledge of MES systems and manufacturing software is a plus.

Responsibilities

• Execute manufacturing processes according to SOPs and procedures.
• Verify and enter production parameters in Batch Records.
• Analyze trend charts and process data for quality control.
• Complete GMP documentation in logbooks and SOPs.
• Maintain compliance with FDA, EPA and OSHA regulations.
• Operate with PPE and maintain a safe working environment.
• Support the production schedule and attend required meetings.

Education

College degree or HS Diploma with +5 years industrial experience

Tools

SAP Production

Werum MES

Compliance-Kaplan Wire

MS Office

MS Word

MS Excel

Job description

Position Details

Job Title: Manufacturing Process Technician / Pharma Manufacturing
Duration: 06 months contract, extendable up to 24 months
Location: Malvern, PA

Note:
Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan which includes dental and vision.

Position Title: Temporary Biotechnician (Scientific Process Operator)
Reports to (Title): Manufacturing Supervisor
Department: Technical Operations
Site: Malvern

Position Summary

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in Downstream Manufacturing. 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 §
• Basic GMP understanding §
• Attend PE awareness classes and may participate PE projects §

Education And/Or Experience

• College degree or HS Diploma with +5 years industrial 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 §

Computer Ability

• Computer literate
• 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

Mathematical Skills

• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. §

Other Skills, Abilities Or Qualifications

• Knowledge and ability to operate manufacturing equipment and hand tools §

Physical Demands

• While performing the duties of this job, the employee: Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. §
• Is frequently required to talk or hear. §
• While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms §
• Ability to lift 20 lbs §

Additional Information

732-947-3452