The Sr. Engineer independently leads and executes complex engineering activities related to process optimization, troubleshooting, system/facility modifications, and capital projects within manufacturing, operations, pilot plant, or engineering environments. This role applies advanced engineering principles, develops technical solutions, directs project execution, and provides expert guidance on methodologies, validation, and documentation in a highly regulated pharmaceutical/biotech setting.
Key Responsibilities
- Lead complex or novel engineering assignments requiring development of new or improved techniques and procedures.
- Develop engineering policies and procedures impacting multiple organizational units.
- Supervise, coordinate, and review work from engineers, associates, and technicians on both ongoing and project‑based tasks.
- Apply advanced engineering techniques and adapt specialized methods to diverse assignments.
- Utilize engineering knowledge beyond core discipline to support cross‑functional initiatives.
- Serve as a peer‑recognized subject matter expert (SME) in at least one engineering technology area.
- Plan and conduct engineering projects using mature technical judgment and scientific methodology.
- Develop technical solutions to complex problems requiring creativity, innovation, and engineering expertise.
- Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for major system or facility modifications.
- Partner with Project Managers to deliver engineering projects within schedule, budget, and quality expectations.
- Coordinate external consultants, architects, and engineering firms in developing standard design documentation.
- Develop departmental or multi‑disciplinary project budgets and manage cost controls for assigned areas.
Skills
- Working knowledge of pharmaceutical/biotech manufacturing processes.
- Familiarity with validation processes, protocol execution, and documentation in regulated environments.
- Ability to interpret and apply GLP, GMP, GDP and engineering science to production systems.
- Ability to operate specialized laboratory and engineering equipment.
- Technical report writing and verbal communication skills.
- Comprehensive understanding of validation requirements for new equipment installations.
- Ability to manage multiple projects simultaneously and determine when additional internal/external resources are required.
- Ability to manage contractors, vendors, and cross‑functional teams.
- Working knowledge of financial analysis tools and project cost development.
- Ability to develop schedules, manage change, and ensure completion and follow‑up of engineering tasks.
Requirements
Required Education
- Doctorate in Engineering, OR
- Master’s degree + 2 years of engineering experience, OR
- Bachelor’s degree in Engineering + 4 years of engineering experience
Preferred Qualifications
- Experience with packaging equipment.
- Experience in design of new equipment or processes.
- Engineering project experience (capital projects, system modifications, facility upgrades).
- Strong knowledge of validation (equipment, process, CSV).
- Experience in medical device or pharmaceutical manufacturing environments.
- Bilingual (English/Spanish)
Benefits
- 8-month contract with possible extension
- Administrative Shift
Skills Required
- Education: Doctorate in Engineering OR Master's degree + 2 years engineering experience OR Bachelor's degree + 4 years engineering experience
- Working knowledge of pharmaceutical/biotech manufacturing processes
- Familiarity with validation processes, protocol execution, and documentation in regulated environments
- Ability to interpret and apply GLP, GMP, GDP and engineering science to production systems
- Ability to operate specialized laboratory and engineering equipment
- Technical report writing and verbal communication skills
- Comprehensive understanding of validation requirements for new equipment installations
- Ability to manage multiple projects, contractors, vendors, and cross-functional teams
- Working knowledge of financial analysis tools and project cost development
- Experience with packaging equipment
- Experience in design of new equipment or processes
- Engineering project experience (capital projects, system modifications, facility upgrades)
- Strong knowledge of validation (equipment, process, CSV)
- Experience in medical device or pharmaceutical manufacturing environments
- Bilingual (English/Spanish)
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
