Process Engineer

Intellectt Inc; New Jersey; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a dynamic Sr. Medical Device, Pharmaceutical & Engineering Recruiter to join their team. This role involves providing leadership in Operations Engineering, focusing on process requirements and specifications in manufacturing. You will engage in root cause analysis, review complex validations, and optimize manufacturing processes. The ideal candidate will have a strong engineering background, excellent problem-solving skills, and the ability to manage multiple projects under tight deadlines. If you're passionate about making a significant impact in the medical device and pharmaceutical sectors, this opportunity is for you.

Qualifications

• 6+ years of engineering experience in the medical device or pharmaceutical industry.
• Strong skills in specification development, design, and troubleshooting.

Responsibilities

• Lead engineering support for manufacturing processes and continuous improvement.
• Conduct root cause analysis and validate complex processes.

Skills

Time Management

Problem Solving

Interpersonal Communication

Project Management

Education

Bachelor’s degree in engineering or science

Equivalent technical experience

Job description

Direct message the job poster from Intellectt Inc

Sr. Medical Device, Pharmaceutical & Engineering Recruiter

Role: Process Engineer

Location: Remote (New Jersey)

Duration: 6+ Months

Responsibilities:

1. Provide Operations Engineering leadership and support for process requirements and specifications in manufacturing processes, formulation, including design transfer, process validation, product line extensions, and continuous improvement activities in a cross-functional environment.
2. Conduct effective root cause analysis to investigate issues relating to products and processes, providing leadership and support throughout the process.
3. Review strategies and designs for complex validations, including novel equipment and processes.
4. Review SOPs, validation protocols, qualifications protocols, and batch records for complex validations, executing validation/qualification protocols.
5. Challenge experimental designs, engineering principles, process excellence principles, problem-solving principles, and design for manufacturability related to process changes, technology, and/or new product transfers.
6. Work with CMO to optimize and scale manufacturing.

Qualifications:

1. Bachelor’s degree in engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 6+ years of significant engineering and/or operational experience.
2. Experience with dual chamber device/injectables, aseptic manufacturing, saline filling.
3. Solid time management, organization, and follow-through skills with the ability to work on and manage multiple tasks and projects with tight deadlines. Ability to exercise professional discretion and judgement.
4. Experience with new product, equipment, and/or technology development in the medical device or pharmaceutical industry, including proven skills in specification development, design, fabrication, qualification, and troubleshooting.
5. Ability to present to management team, challenge issues, defend strategy, timing, resource needs, risks, and plan.
6. Ability to analyze issues and develop and deploy solutions.
7. Established strong verbal, written, and interpersonal communication skills with an ability to interface at all levels of the business environments.

Seniority level

Not Applicable

Employment type

Contract

Job function

Pharmaceutical Manufacturing