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Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

Schedule: Candidate will work 1st shift primarily. Shift Hours: 1st, 7:00am - 3:30pm

Interview Process: Two Rounds, first round phone screen, second round onsite panel interview

Note: Candidates must be compliant with DOD/ITAR requirements.

Responsibilities:

• The process technician level II will have a primary focus on plant logistic support. With this, the incumbent will have to come to our site and learn about our state-of-the-art glass making process and then assist us in creating routings for our process.
• This includes entering production information into our facility data system and maintaining other data sources as required.
• This position will involve the transportation of parts (making sure the parts are in the right location and move throughout the plant as planned).
• This will include making sure we have all the supplies needed to handle and move the parts within the plant and to our suppliers.
• Also this position will work with many engineers and scientists to understand the new product flows throughout the plant so they can develop the new routes in our production system.

A full list of responsibilities that the process technician level II should work toward fulfilling includes supporting our day-to-day operations and process development for Trident product manufacturing including in order of most used skills on a day-to-day basis:

Plant Logistics Support:

• Routings: Enter Production Information into Facility Data System and Maintain Other Data Sources as Required.
• Transport Parts and Supplies.
• Maintain Inventory of Production Consumables and Parts.

Documentation:

• Support the Creation of SOS and SOPs.
• Revise and Refresh process documentation.

Lean Manufacturing:

• Support Initiatives to Optimize Manufacturing Processes (5S, Lean Principles).
• Engage in Information Sharing to Improve Overall Process.

Product Inspection Support:

• Perform Metrology Measurements as Needed.
• Support A-LIIST Metrology When necessary.
• Inspect Other Quality Metrics as Requested.

Equipment Support:

• New Equipment Installation and Qualification Support.
• New and Novel Methods for Operating Existing Equipment.

Preventative Maintenance:

• Identify PMs Needed for Equipment.
• Document PM Requirements.
• Perform PM as Appropriate.

Experiment Execution:

• Part Tracking
• Performing Experiments
• Equipment Set-up and Operation
• Data Recording
• Product Sampling
• Communication of Status, Issues, and Ideas

Education and Experience:

• BA degree preferred, Associate's or HS Diploma/GED with relevant experience - minimum required.
• 3-7 years preferred (5+ years desired), experience in supporting plant logistics including material supply.
• Highly proficient with Microsoft Office tools such as Word, Excel, PowerPoint, & Outlook.
• Collaborate with key stakeholders to complete assigned tasks.
• Experience with scheduling tools, navigating stakeholder and location availability.

Desired Skills:

• Strong organizational and prioritization skills with the ability to manage multiple projects, deadlines, and stakeholders simultaneously.
• Exceptional attention to detail in data entry, documentation, scheduling, and reporting.
• Ability to anticipate needs, follow up on open items, and independently resolve routine issues.
• Professional written and verbal communication skills for interacting with engineers, leadership, vendors, and cross functional teams.

Senior Process Improvement Engineer – Medical Device Manufacturing

Athens, TX

$60–$80/hr (Based on relevant experience)

Contract-to-Hire | Direct Hire possible for standout talent

Kelly Engineering is recruiting a senior-level Process Improvement Engineer for a medical device manufacturing site in Athens, TX that needs immediate process stabilization and quality improvement.

This role is built for a hands-on “fixer”. You’ll be stepping into manufacturing processes, addressing real quality issues, and helping redesign workflows to stabilize and optimize production in an FDA-regulated environment.

What You’ll Be Doing

• Fix and redesign inefficient manufacturing processes
• Reduce scrap, rework, defects, and operational risk
• Lead hands-on Lean and continuous improvement efforts
• Address quality issues at the root cause level
• Work directly on the manufacturing floor with Ops and Quality

What We’re Looking For

• 5–12 years of medical device manufacturing experience
• FDA-regulated environment (Class II / 510(k))
• Manufacturing, Process, or Industrial Engineering background
• Proven experience fixing poorly designed or unstable processes
• Comfortable working under quality and regulatory pressure

Why This Role Stands Out

• High-impact, hands-on work
• Real ownership and visibility
• Direct hire is on the table for the right candidate
• Hourly rate flexibility for rockstar candidates with relevant experience

Candidates without medical device manufacturing experience will not be considered.

If you’re known for walking into tough manufacturing environments and fixing problems, this is the role for you.

Company Description

Omega EMS has been at the forefront of developing and delivering cutting-edge solutions in Silicon Valley. Our expertise makes us uniquely equipped to supply unparalleled customer service tailored to each individual need – all within a framework that is firmly rooted in CGMPs (Current Good Manufacturing Practices). With our flexible approach, real world operational experience and commitment to serving customers’ needs with excellence, Omega EMS offers an incomparable “one stop solution” for any EMS project.

Role Description

The Process Technician will be a key contributor to Omega EMS’s SMT line, AXI, and process engineering activities for PCB assembly. This role is responsible for ensuring that every stage of the printed circuit board assembly process meets the highest standards of quality and reliability. The ideal candidate is a resourceful problem solver who can overcome technical challenges and implement practical solutions. As a core member of the manufacturing team, the Process Technician works closely with production operators, engineers, and quality staff to support fast-paced, high-mix builds for Silicon Valley’s most innovative companies, delivering world-class manufacturing systems and processes.

Qualifications

Job Responsibilities:

·        Serve as the first line of technical support for PCB assembly production, troubleshooting and resolving process issues in real time.

·        Set up, inspect, and validate SMT equipment and processes, including stencil printers, reflow ovens, SPI, and X-ray, to ensure high-quality first articles and stable production runs.

·        Contribute to the design and fabrication of stencils, tooling, and fixtures, and manage the tooling log to maintain availability and accuracy.

·        Perform X-ray and visual inspections, identify solderability or void issues, and implement corrective actions where needed.

·        Provide hands-on training and guidance to operators and production staff, improving process understanding and capability across the team.

·        Support and collaborate with SMT, AXI, and Engineering on technical inquiries and escalations; elevate unresolved issues to the Supervisor as necessary.

·        Collect and analyze process data to identify trends, drive systemic improvements, and enhance yield and throughput.

·        Maintain a strong focus on safety, quality, and continuous improvement, while being adaptable and open to learning new tasks as required.

Job Requirement:

·        3+ years of hands-on PCBA experience (5+ years preferred).

·        Strong working knowledge of SMT/PCBA processes, including screen printer programming, solder paste inspection, reflow profiling, and X-ray inspection.

·        Ability to read and interpret wiring diagrams, schematic drawings, and engineering instructions, applying knowledge of electronic theory and components.

What We Offer

Paid Vacation

Paid Holidays

401K/ Roth 401K

Medical, Dental, and Vision

**This is a swing shift hourly role and you will earn between $25 and $27 plus 10% differential.

Job Title: Process Engineer, with 5axis CNC experience - Advanced Manufacturing

Location: Stow, OH

Salary: $80,000-$120,000

About the Role:

Join our dynamic team as a Process Engineer, where you'll be at the forefront of developing and optimizing manufacturing processes for complex product lines. This isn't just an engineering role - it's an opportunity to shape production systems, mentor team members, and drive real innovation on the shop floor. If you're passionate about turning designs into reality and thrive in a hands-on manufacturing environment, we want to hear from you.

What You'll Do:

• Lead process development and optimization for new product launches and existing manufacturing lines
• Create and optimize CNC programs using advanced CAM software (Mastercam preferred)
• Design and validate custom tooling, fixtures, and equipment using 3D modeling (AutoCAD Inventor or similar)
• Drive continuous improvement initiatives using Lean manufacturing principles
• Serve as the manufacturing expert for cross-functional teams, providing technical guidance
• Troubleshoot complex manufacturing challenges in a machining environment
• Develop and implement process improvements that reduce waste and enhance quality

What You Bring:

• 5-10 years of hands-on manufacturing engineering experience
• Expertise in CAD/CAM software and CNC programming (5-axis experience required)
• Proficiency in 3D modeling and blueprint reading with strong GD&T knowledge
• Demonstrated experience in tooling selection and fixture design
• Proven ability to solve complex manufacturing problems using data-driven approaches
• Strong leadership skills with experience mentoring junior engineers
• Excellent communication skills and ability to thrive in a collaborative environment

Why Join Us?

• Competitive compensation and comprehensive benefits package
• Opportunity to work with state-of-the-art manufacturing technology
• Strong focus on professional development and continuous learning
• Collaborative team environment that values innovation
• Clear career growth path with opportunities for advancement

Ready to Make an Impact?

If you're ready to take your manufacturing engineering career to the next level, apply now! We're excited to meet passionate engineers who are ready to drive manufacturing excellence.

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#Hiring #ProcessEngineer #ManufacturingEngineer #CNCProgramming #EngineeringJobs #LeanManufacturing #CADCAM #NowHiring #ManufacturingCareers

TekPro is partnered with a precision machining manufacturer in the Chicago area that is looking to add a Process Engineer to their team. Our client offers modern CNC equipment, a clean and organized facility, and the opportunity to work on complex precision machined components.

This role is ideal for someone with experience in a precision machining environment who enjoys developing manufacturing processes, working with engineering and production teams, and supporting the launch of new parts into production.

Key responsibilities include:

• Developing detailed manufacturing process plans for new parts using SolidWorks for modeling and drafting and Visual Manufacturing (ERP) for documentation
• Reviewing customer purchase orders, drawings, and specifications to ensure all requirements are incorporated into the manufacturing process plan
• Ensuring manufacturing process plans comply with all drawing, purchase order, and specification requirements
• Reviewing existing tooling and gage inventory for use in the manufacturing process
• Designing and ordering new tooling when necessary
• Working closely with manufacturing teams to troubleshoot and resolve production issues as they arise
• Supporting continuous improvement of manufacturing processes and production efficiency

If you have experience in manufacturing engineering or process engineering within a CNC machining environment and are interested, apply now to learn more!

We are seeking a highly skilled and detail-oriented P&ID Designer or Process Engineer to join our engineering team. The ideal candidate will have hands-on experience in creating and revising Piping and Instrumentation Diagrams (P&IDs) using AutoCAD, Revit, and Plant 3D, with a strong understanding of ISO and industry standards. This role is critical to ensuring accurate documentation of process systems for industrial, manufacturing, or energy projects.

Key Responsibilities:

• Design and revise P&IDs for process systems in compliance with ISO and project-specific standards.
• Collaborate with mechanical, electrical, and process engineers to ensure accurate system representation.
• Use AutoCAD Plant 3D and Revit to model piping layouts, instrumentation, and equipment.
• Maintain and update engineering documentation, including BOMs, datasheets, and control narratives.
• Conduct quality checks and ensure drawings meet regulatory and safety requirements.
• Support project teams during design reviews, construction, and commissioning phases.
• Integrate P&IDs with 3D models and databases for intelligent documentation and asset tracking.

Qualifications:

• Bachelor’s degree in mechanical, Chemical, or Industrial Engineering (or equivalent experience).
• 3+ years of experience in P&ID design or process engineering.
• Proficiency in AutoCAD, Revit, and Plant 3D.
• Strong knowledge of ISO standards and ANSI/ISA instrumentation symbols.
• Familiarity with process control systems and industrial equipment.
• Excellent attention to detail and organizational skills.
• Strong communication and collaboration abilities.

Preferred Skills:

• Experience with SmartPlant P&ID or AVEVA Diagrams.
• Knowledge of BIM workflows and integration.
• Understanding of process safety and HAZOP documentation.
• Ability to automate tasks using scripts or macros in CAD environments.

At BayCare, we are proud to be one of the largest employers in the Tampa Bay area. Our network consists of 16 community-based hospitals, a long-term acute care facility, home health services, outpatient centers and thousands of physicians. With the support of more than 30,000 team members, we promote a forward-thinking philosophy that’s built on a foundation of trust, dignity, respect, responsibility and clinical excellence.

Manager Sterile Processing Position Details:

• Title: Manager Sterile Processing
• Location: Winter Haven Hospital, FL
• Status: Full Time, Exempt:
• Shift Hours: 8:00 AM - 4:30 PM
• Weekend Work: Occasional
• On Call: No

When you become a BayCare leader, we support your personal and professional growth by offering a range of benefits, educational opportunities and a healthy work-life balance:

• Benefits (Health, Dental, Vision)
• Paid time off
• Tuition reimbursement
• 401k match and additional yearly contribution
• Yearly performance appraisals and leadership award
• Community discounts and more
• Relocation assistance if eligible
• AND the Chance to be part of an amazing team and a great place to work!

The Manager Sterile Processing responsibilities include leadership within the health system demonstrating proficiency in all Quality Leadership skills.

• Expertly manages the entire operation surrounding the sterile processing of instruments and other items necessary to conduct patient care throughout the hospital
• Assumes 24-hour responsibility for the Sterile Processing Department
• Acts as liaison between staff, team members, physicians, other customers and administration
• Perform other duties as assigned

Qualifications

• Sterile Processing Experience:
• Minimum of 3 years of Sterile Processing experience OR
• 5 years of related experience in lieu of an associate degree
• Leadership Experience:
• Minimum of 3 years of management experience OR
• 5 years in a coordinator role within a related field

Education & Certifications

• Associate degree required
• CRCST (Certified Registered Central Service Technician) required
• If an associate degree is not held, the CRCST certification is required in its place
• Bachelor’s degree preferred
• CBSPD – CSIS (Certified Surgical Instrument Specialist) preferred

Founded in 1926, Winter Haven Hospital has an outstanding reputation for superior, patient-centered care. Our mission statement is "to improve the health of the people we serve, by providing the highest quality and most effective care and services -- and to return value to the people in our communities." By upholding this standard of excellence in all that we do, we are able to provide patients throughout central Florida with customized, state-of-the-art treatments in a comfortable environment.

Ready to Lead? Join BayCare and make a lasting impact. Apply today and take your career to the next level!

Equal Opportunity Employer Veterans/Disabled