Senior Specialist Engineering; Onsite

Job Description The Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization, which enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites. The SSO Process Supervisor assists on daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements in addition to the existing labor contract to meet SSO objectives and customer requirements.

The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements. This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and cross-functional SSO partners to drive overall success and performance of the building.

This role will also be responsible for the prioritization and assignment of daily activities for the operations staff.

Ensure processes are run within the capability constraints of the facility. Execute batch processes as needed from either a hands-on role or a supervisory role. Ensure facility equipment readiness with respect to repair, cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory. Write, issue, and review GMP documentation. Provide input for incident root-cause analysis, reporting, and action items.

Facilitate and drive building improvement projects and CAPA (Corrective Action and Preventive Action) completions. Provide input on and proficiently execute process setups. Provide regular feedback (both constructive and positive) to peers to promote a continuous improvement mindset. Collaborate with all building staff to share and align on best practices. Actively investigate problem statements and SORs (Safety Observation Reports) to promote fast and efficient problem resolution.

Understand hazardous/high risk-work and issue permits as needed. Identify opportunities to improve building efficiency, compliance, and safety. Support training, mentoring, and coaching of operations staff.

Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 5 years of relevant experience in a process development lab or pilot plant/manufacturing facility - OR
- Associates degree with at least 8 years of relevant experience in a process development lab or pilot plant/manufacturing facility - OR
- High school diploma with at least 10 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

Mechanical aptitude and familiarity with chemical process development and process equipment. Experience supervising a team of shop floor personnel in an operations environment. Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations. Experience operating/maintaining pilot scale or manufacturing scale equipment. Effective communication skills and a collaborative mindset. Experience in conflict resolution and root cause analyses.

Ability to build effective work relationships with a strong workforce. Adaptable to a dynamic production environment. Relevant experience in a process development lab or pilot plant/manufacturing facility.

Lean Six Sigma Training / Certification. Experience with small molecule drug substance and/or biologics process development. #MSJR #PRD #eligibleforERP

Chemical Engineering, Collaborative Leadership, Competency Management, Efficiency Improvements, Employee Training, Equipment Qualification, Good Manufacturing Practices (GMP), Industrial Processes, Manufacturing, Operations Support, Process Control, Process Hazard Analysis (PHA), Process Optimization, Safety Compliance, Technical Leadership

US and Puerto Rico Residents Only:
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