
Posted a day ago
Senior Process & Systems Engineer
BioPharma Consulting JAD GroupSenior Process & Systems Engineer
Perks & benefits
AccommodationHealth InsurancePaid Leave
Requirements
Doctorate OR Master's + 2 years experience OR Bachelor's + 4 years experience, Pharmaceutical or biotech process knowledge, Validation process expertise, GLP/GMP requirements knowledge, Technical report writing, Project management skills
Skills
GMPSAPTrackwiseVeeva
About the role
Responsibilities
- Lead process optimization and troubleshooting initiatives across manufacturing, pilot plant, and capital project environments.
- Design and implement major system modifications, experiments, and engineering solutions using advanced engineering principles.
- Develop engineering policies and procedures that impact multiple organizational units.
- Supervise and review the work of engineers, associates, and technicians on project-specific bases.
- Collaborate with Research, Manufacturing, Quality Assurance, and Validation teams to define requirements for complex facility modifications.
- Partner with Project Managers to deliver engineering and design projects within scope, schedule, budget, and quality expectations.
- Coordinate with external consultants, architects, and engineering firms to develop standard design documentation.
Requirements
- Doctorate OR Master's degree + 2 years of engineering experience OR Bachelor's degree in Engineering + 4 years of engineering experience.
- Working knowledge of pharmaceutical or biotech processes.
- Expertise in validation processes and protocol execution.
- Strong knowledge of GLP/GMP requirements and documentation in highly regulated environments.
- Proven technical report writing and verbal communication skills.
- Strong project management, analytical problem-solving, and engineering calculation skills.
Preferred Qualifications
- Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering.
- Experience supporting Drug Substance processes in biotechnology or pharmaceutical operations.
- Proficiency with SAP, TrackWise, electronic batch records (PAS/X), and Veeva document management systems.
- Technical knowledge of inspection technologies for parenteral and glass containers.
- Experience directing technical resources such as Mechanics, Automation Technicians, and IS teams.
- Bilingual capabilities in English and Spanish.
Benefits
- 1-year contract
- Administrative Shift
About the Company
BioPharma Consulting JAD Group provides specialized engineering and consulting expertise within the biotechnology and pharmaceutical sectors.
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BioPharma Consulting JAD Group · Juncos
