Senior Specialist Engineering (Onsite)

Caraway Therapeutics, Inc.; Rahway (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Caraway Therapeutics, Inc. is seeking a Process Supervisor for the Small Scale Organics Pilot Plant within PR&D.

You will oversee daily production activities, ensure GMP and safety compliance, and drive CAPA projects while coordinating with cross-functional teams to meet customer requirements. The role emphasizes facility readiness for API processing, supervising shop-floor staff, and prioritizing daily activities.

Qualifications

• Bachelor's degree with at least 5 years of relevant experience in a process development lab or pilot plant/manufacturing facility
• Associates degree with at least 8 years of relevant experience in a process development lab or pilot plant/manufacturing facility
• High school diploma with at least 10 years of relevant experience in a process development lab or pilot plant/manufacturing facility

Responsibilities

• 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, 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 completions.
• Provide input on and proficiently execute process setups.
• Provide regular feedback 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 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.

Skills

Chemical Engineering

GMP

GDP

Process Development

Leadership

Safety

Root Cause Analysis

Education

Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related field

Associates degree with 8+ years of experience

High school diploma with 10+ years of experience

Job description

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.

Responsibilities:

• - 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.

Education Minimum Requirement:

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.

Required Experience and Skills:

• - 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.
• - This role requires working on 8-hour shifts that rotate between 1st and 2nd shift on alternating weeks throughout the year. Onsite presence is required five days a week. Occasional overtime work may be required based on business needs.

Preferred Experience and Skills:

• - Lean Six Sigma Training / Certification.
• - Experience with small molecule drug substance and/or biologics process development.

#MSJR

#PRD

eligibleforERP

Required Skills:

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

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
At times will work with hazardous materials

Job Posting End Date:
10/22/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.