Biologics Process Operator

Company Name:
The Judge Group
Job ID: 419020
Job Title: Biologics Process Operator
Job Type: Contract
Location: Devens, MA
Contact E-mail:
Salary: Open
Description: Our client, a large pharmaceutical company, is currently seeking a Biologics Process Operator.
The Senior Bioprocess Specialist assists in the execution of commercialmanufacturing process according to established electronic work instructions andproduction records for the manufacture of therapeutic proteins in accordancewith current Good Manufacturing Practices (cGMP's).
This job will have the following responsibilities:
1. Works on routine manufacturing assignments as well as assignments thatare complex in nature where action and a high degree of initiative are requiredin resolving problems and making recommendations.
2. Adheres to Good Manufacturing Practices andstandard operating procedures.
3. Weighs and checks raw materials. Assembles, cleansand sterilizes process equipment, monitors processes.
4. Completes electronic work instructions andmaintains clean room environment to comply with regulatory requirements.
5. Operates all production equipment and systems tosupport biologics production of downstream unit operations (i.e. glass washers,Buffer equipment, chromatography skids, membrane operations, column packingskids, etc.)
6. Effectively uses and possess mastery for processautomation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian)and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
7. Ensures less experienced manufacturing personnelcomply with Standard Operating Procedures (SOPs) and electronic workinstructions and that training is completed on time.
8. Under direction of supervisor or Technical SME,leads the coordination and implementation of special projects such asvalidation or complex investigations.
9. Revises and creates process documents with noinstructions, supports routine process investigations independently.
10. Reviews batch and exception reports for eachmanufacturing lot in conjunction with Quality representative. Follows throughexceptions and resolves issues. Also assists with developing CAPAs. DevelopsCAPA as necessary to expedite lot release.
11. Champions areas specific initiatives associatedwith work safety
12. Engages in and supports culture of continualimprovement through ownership of improvement for work processes, equipment andsafe work environment. Advises Shift supervisor on improvements which mayoptimize work processes. Works on Routine manufacturing
13. Functional specifications will be developed forautomation code associated with Delta V units and phases, and will includefunctional descriptions. Documents will include interlocks, phase tables,equipment modules, control modules, and all associated parameters.
14. Functional specifications are also required forSyncade recipes; these will be high level and will include batch recordrequirements and process related parameters. Will also document requiredcritical and process parameters associated with a particular process step.
Qualifications & Requirements:
High school diploma is required. Knowledge of science generally attainedthrough studies resulting in a B.S., in science, engineering, biochemistry orrelated discipline, or its equivalent is desired but not required.
o A minimum of 10+ years process operations experiencein a highly automated biotechnology manufacturing facility subject to GoodManufacturing Practices (GMP) regulations.
o Strong knowledge of downstream unit operation isessential.
o Practical knowledge of regulations such as GMP andcompany Standard Operating Procedures (SOP).
o Prior evidence of successful participation on workteams where combined contribution, collaboration, and results were expected
o Demonstrated proficiency in common computer toolssuch as word processing, spreadsheet and web based applications.
o Previous work experience where attention to detailand personal accountability were critical to success
o Demonstrates good interpersonal skills, is attentiveand approachable.
o Maintains a professional and productive relationshipwith area management and co-workers.

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