Manufacturing/Engineering Support Associate

Job Description

Seeking candidates for an Associate Specialist position in the company's Research Laboratories (Research Division) Biologics Pilot Plant (BPP) supporting the Biologics Support Operations (BSO) Front-Line Managers.  The candidate will work under the direction of a front-line manager in a dynamic environment, supporting compliance and operations objectives in aid of multiple pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. Candidate will specifically support areas focusing on media and buffer manufacture, raw material weight and dispense, sterile tubing assembly and packaging, and GMP cleaning activities.

Tasks:

Candidate will participate in a range of activities including, but not limited to:

• Support safety, compliance, and GMP initiatives

• Prepare, Review, and update GMP Documentation (e.g., Standard Operating Procedures)

• Work with team members in identification and implementation of continuous improvement initiatives and actions plans

• Data entry, log management, and batch record reviews

• Under the direction of front-line managers, the candidate will help to motivate others, ensure performance, coordinate tasks, and support effective administration of personnel policies and procedures

• Participate in investigations and change management activities

• This is a developmental role with an opportunity to build a foundation into a front-line manager position. 

Education:

• BS/BA in Biological Sciences, Chemistry, Engineering or related.

Experience/Skills:

• Comprehension of the regulatory guidelines governing GMP manufacture is important. The candidate will work in a team atmosphere in close partnership with (but not limited to) raw material release teams, facility operations, equipment engineering, process operations, safety, our Manufacturing Division Partners, and quality groups.

Qualifications:

• Work both independently and in a team setting

• Demonstrated ability to manage multiple tasks and priorities

• Effective problem-solving skills

• Effective technical communication skills

• Good comprehension of Microsoft Office Applications, including SharePoint and Power Platform Tools.

• Some overtime (including weekends) and occasional second shift work may be necessary. Carrying an on-call phone to support off-hour manufacturing will be required. 

Preferred:

• Knowledge of SAP

• Knowledge of current GMP regulations

• Has worked within a Union Environment

• Has worked in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)

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