Engineering Support Specialist

Engineering Specialist

Seeking candidates for an Engineering 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 Director 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:

• Participate in or manage Quality Notification investigations and change management activities
• Order process consumables used in GMP manufacturing activities
• Submit requests for supply chains to Third Party Quality Management.
• Research and manage supplier notifications at the direction of the supplier notification lead.
• Prepare, Review, and update GMP Documentation (i.e. Standard Operating Procedures, Bills of Materials, Batch Records)
• Content expert and trainer for select procedures
• Data entry and electronic log creation and management
• Assist with PAS-X administrative work (i.e. parameter value list (PVL) updates/ Change Controls/ Manufacturing Order (MO) creation, coordinating QA approval)
• Assist with warehouse coordination (i.e. scheduling sampling, risk release management, deliveries, SAP management)
• Assist with equipment troubleshooting and calibration coordination
• Work with team members in identification and implementation of continuous improvement initiatives
• Support safety, compliance, and GMP initiatives including conducting area walkthroughs and managing/closing observations
• 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.
• This is a developmental role with an opportunity to build a foundation into a front-line manager position.

Experience/Skills:

• Comprehension of the regulatory guidelines governing GMP manufacture is required.
• 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, manufacturing division and quality groups.

Education:

• BS/BA in Biological Sciences, Chemistry, Engineering or equivalent combination of education and experience.

Required Qualifications:

• Knowledge of current GMP regulations.
• 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.
• Experience with SAP.

Preferred Qualifications:

• Knowledge of PAS-X Manufacturing Execution Systems.
• Knowledge of Ariba system.
• Knowledge of the Electronic Supplier Transparency Request system.
• Knowledge of ETQ Reliance system for supply chain notifications.
• Experience working within a Union Environment.
• Has worked in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.).

Required Skills:

Adaptability, GMP Compliance, Pilot Plant Operations, Process Optimization, Standard Operating Procedure (SOP) Writing, Task Management, Teamwork

Preferred Skills:

Engineering Support, Process Engineering, Process Operations, Regulatory Compliance