Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Engineering Lead
Qualifications:
Bachelor's Degree in Engineering.
Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
Available to work extended hours, possibility of weekends and holidays.
Job Description:
The Engineering Lead will oversee and guide the engineering team responsible for supporting pharmaceutical manufacturing, process improvements, and new product introductions. This role requires deep technical expertise, strong leadership skills, and experience in the pharmaceutical industry, ensuring that engineering solutions meet regulatory standards, enhance operational efficiency, and align with business objectives.
Key Responsibilities:
Leadership & Management: Lead, mentor, and develop a multidisciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement.
Project Management: Oversee the design, implementation, and optimization of manufacturing processes, systems, and facilities, ensuring projects are delivered on time, within scope, and budget.
Compliance & Quality: Ensure all engineering activities comply with regulatory requirements (e.g., FDA, cGMP, ISO), safety standards, and internal quality systems.
Process Optimization: Identify and implement process improvements to increase efficiency, reduce costs, and enhance product quality.
New Product Introduction (NPI): Collaborate with R&D, Quality, and Operations to successfully scale up and launch new products from development to full-scale manufacturing.
Risk Management: Conduct risk assessments and develop mitigation strategies for engineering projects and operations.
Stakeholder Engagement: Work closely with cross-functional teams, including Quality, Production, R&D, and Supply Chain, to align engineering efforts with organizational goals.
Technology Transfer: Manage the transfer of technology from R&D to manufacturing, ensuring smooth scaling and commercialization.
Vendor Management: Collaborate with external suppliers and contractors to ensure timely delivery and adherence to specifications.
Budgeting & Reporting: Manage the engineering budget, track project costs, and report on progress to senior management.
Regulatory Knowledge: In-depth knowledge of pharmaceutical regulations, including cGMP, FDA, and other relevant standards.
Technical Expertise: Strong understanding of pharmaceutical manufacturing processes, equipment, validation, and technology transfer.
Leadership Skills: Proven ability to lead, develop, and motivate a high-performing engineering team.
Project Management: Experience with managing complex engineering projects from concept through completion.
Problem-Solving: Strong analytical and problem-solving skills with a focus on continuous improvement.
Communication: Excellent verbal and written communication skills, with the ability to effectively collaborate with cross-functional teams and stakeholders.
Software Proficiency: Familiarity with engineering software, process simulation tools, and project management software.
Knowledge of environmental, health, and safety (EHS) regulations.
