Description:
BMS Cruiserath Biologics is seeking to recruit on a permanent Senior Specialist, Manufacturing Engineer (Upstream). Reporting to the Senior Manager, Manufacturing Engineer, the Manufacturing Engineer will be the System Owner for Downstream Process Equipment providing engineering support for Manufacturing systems and equipment.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.
Key Duties And Responsibilities
- Responsible for Manufacturing Equipment within the Multi-Product Cell Culture (MPCC) building, including but not limited to Inoculation, Single Use Bioreactors, Seed/Production Bioreactors, Centrifugation and Harvest and Process Support Systems (Media Preparation and Media Hold).
- Provide support to Manufacturing with primary focus on troubleshooting equipment and automation issues.
- Supporting/leading manufacturing and process equipment investigations.
- Engineering owner for specific manufacturing areas and systems, focused on acquiring an in-depth knowledge of process operations and process equipment to support Manufacturing, Quality, Automation and Validation.
- Ensuring system compliance with all Regulatory requirements including Quality (cGDP/GMP’s), and EHS requirements & procedures.
- Supporting internal and external audits as the Manufacturing Engineering Technical resource.
- Responsible for Clean in Place (CIP) and Steam in Place (SIP) changes, optimisations and support of Validation through periodic assessment.
- Accountable for redlining, reviewing, and approving of Automation Functional Specifications and ensuring implementation of software changes to the Process Automation System (PAS).
- Manufacturing engineering equipment lead for new product introduction with support for equipment capability assessments, new equipment requirements and recipe design.
- Develop goals into appropriate scope and deliverables with demonstrated ability to meet agreed timelines. Plan and execute work assignments with ability to interpret results and report out to peers and stakeholders.
- Have a systematic approach to completing work activities, be willing to take on new activities, look to improve and contribute to building a sense of purpose within the team.
- Perform but not be limited to the following activities: Periodic FMEA review of owned equipment, addressing equipment issues identified by production teams, assessing production needs opportunities, reducing equipment downtime, support of compliance efforts related to Investigations, CAPA and change management.
- Champion the use of continuous improvement.
Qualifications, Knowledge And Skills Required
- The successful candidate will have a BS in Engineering (Chemical or Mechanical preferred) with 2-3 years plus experience (or equivalent) with manufacturing equipment support in the Biotechnology manufacturing industry.
- Knowledgeable and experienced in engineering principles related to typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra-filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and parts washers.
- Candidates must be effective in both a team environment and an individual contributor role with minimal supervision.
- Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability.
- The job requires high level of technical knowledge, and the candidate should have the ability to proactively troubleshoot.
- Knowledge of Delta V, or other process automation software required; ability to use process historian and analyze data to assist troubleshooting.