Manufacturing Engineer II

Manufacturing Engineer II
$85K to $95K
Western Broward County, South Florida
On-site | Full-time
Reports to: Senior Manufacturing Engineer
Relocation Assistance Available
 
ttg Talent Solutions has been engaged to conduct a search for a Manufacturing Engineer II on behalf of a well-established pharmaceutical manufacturer with a broad portfolio of generic and branded products. Based on-site in Western Broward County, this hands-on role supports both new product introduction and lifecycle management of drug-device combination products, working at the intersection of product development and production.
Position Summary
The Manufacturing Engineer II will support design transfer, process development, validation, production readiness, and continuous improvement for regulated drug-device combination products. The role partners closely with Quality, R&D, Operations, supply chain, suppliers, and other technical stakeholders to establish robust manufacturing controls, solve production issues, and maintain compliant engineering documentation. Experience with inhalation or nasal drug-delivery platforms is highly valued.
Key Responsibilities
Design Transfer and New Product Introduction

• Contribute to design transfer activities and new product introduction programs through active cross-functional engagement with Quality, R&D, Operations, and supply chain stakeholders.
• Apply Design for Manufacturing and Assembly (DFx) principles during product development and manufacturing-process development.

Process Development and Validation

• Author and execute process-development activities, including development protocols, preventive maintenance and calibration requirements, and IQ/OQ/PQ validation packages.
• Apply Design of Experiments (DoE), statistical process control (SPC), process capability studies, Gage R&R, and measurement system analysis (MSA) to establish and maintain robust manufacturing-process controls.
• Author and use xFMEAs to proactively identify potential manufacturing defects and minimize risk to patient safety.

Production Documentation and Change Control

• Create and maintain engineering drawings, bills of materials (BOMs), manufacturing travelers, manufacturing-process instructions, and engineering change orders.
• Maintain engineering files in accordance with the site quality system, applicable SOPs, and change-control requirements.

Equipment, Tooling, and Production Support

• Operate, understand, and troubleshoot semi-automatic and fully automatic assembly equipment used in drug-device combination product manufacturing.
• Design, develop, and procure tooling, fixtures, and equipment using SolidWorks; participate in vendor discussions, equipment-specification reviews, and capital procurement.
• Coordinate engineering and production builds and communicate clear manufacturing-process instructions to production teams.

Continuous Improvement and Problem Solving

• Identify and resolve production-line issues involving process or component nonconformances, deviations, equipment problems, and manufacturing inefficiencies.
• Use structured problem-solving methods, including 5-Why, Fishbone, and Is-Is Not, to address complex technical challenges.
• Apply Lean Manufacturing and Six Sigma principles to drive continuous improvement and collaborate with Quality to establish effective process and quality controls.

Stakeholder Communication

• Communicate manufacturing capabilities, production schedules, technical requirements, and risks to management, cross-functional teams, suppliers, and customers.
• Work effectively across technical and non-technical disciplines and multicultural environments to support smooth production execution and timely decision-making.

Required Qualifications

• Education: BS or MS in Mechanical Engineering or an equivalent engineering discipline.
• Experience: Minimum three years of relevant manufacturing engineering experience.
• Regulatory and Quality: Working knowledge of applicable regulatory frameworks, quality assurance requirements, cGMP practices, and relevant ISO, ASTM, and ICH standards.
• Communication: Demonstrated ability to communicate effectively with management, cross-functional teams, suppliers, and customers across technical and non-technical domains and multicultural environments.
• Industry Background: Experience in medical device and/or pharmaceutical manufacturing is strongly preferred.
• Design and Manufacturing Depth: Background in product design, injection molding of plastic components, testing and verification, equipment building, and equipment qualification is highly desirable.
• Drug-Delivery Experience: Hands-on experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays, or nebulizers is a meaningful differentiator.
• Leadership: Leadership or coaching experience and comfort mentoring peers or junior team members are desirable.

Core Competencies

• Collaboration, cross-functional partnership, and stakeholder management.
• Customer and patient centricity.
• Developing talent and supporting others.
• Innovation, creative problem-solving, and strategic agility.
• Process excellence, technical rigor, and results orientation.

Why This Opportunity
This role offers the opportunity to work on technically substantive pharmaceutical manufacturing challenges with direct impact on product quality, process robustness, and patients who depend on these products. The position provides broad cross-functional exposure, hands-on ownership of validation and manufacturing activities, and the opportunity to contribute to both new product introduction and ongoing product lifecycle improvement. Relocation assistance is available for the right candidate.