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In office (Malvern)
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Middle · 5+ years exp
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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§

Anuj Mehta

732-947-3452

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