Gmp (good Manufacturing Practices)

Gmp (good Manufacturing Practices) Engineer Jobs

2 jobs found

30d ago

Engineer V

cGMPnow San Diego County, CA 🇺🇸 Remote

San Diego County, CA

30d ago Closed

$145k - $175k/yr Full time AutoCAD BIM Bluebeam Studio

This position is no longer accepting applications (closed Aug 16, 2026).

Job Description

cGMPnow offers a collaborative, impact-driven environment in the San Diego County area with remote options. This Engineer V position carries a salary of USD 145,000 to 175,000 per year and a comprehensive benefits package including 401(k) with matching, health, dental, vision, paid time off, profit sharing, and charitable contributions matching. The role focuses on process, equipment, and project engineering for complex cGMP capital projects in FDA and EU regulated Advanced Therapeutics, with potential pathways into project management and business development.

What you will do

Gather process data and define project requirements
Develop mass balances and assemble detailed equipment lists for complex cGMP manufacturing and laboratory equipment
Create process description narratives, process flow diagrams (PFDs), and P&IDs
Generate User Requirement Specification documents
Collaborate with facilities, manufacturing, technical operations, and facility planners to address process needs including equipment, space, adjacencies, and flows
Work with the PM and discipline leads to ensure process deliverables are on time, coordinated, and within budget
Research process equipment providers and make recommendations based on project requirements
Write process equipment specifications for complex cGMP manufacturing and lab equipment
Define testing requirements and participate in factory acceptance tests (FATs)
Verify receipt of manufacturing, lab, and process utility equipment
Specify and coordinate installation, startup, and commissioning services by vendors or third parties
Write and update SOPs for new process and project implementations
Support post-construction activities, reviewing submittals, RFIs, and field verification of process scope
Support CAD and Designer staff
Stay current with industry technologies and cost implications of various solutions
Assist the project manager with deliverables per the PEP, budget, schedule, and Quality Plan
Support successful project execution using client procedures and industry best practices
Manage project changes in scope, schedule, and budget
Identify and mitigate project risk
Support project team meetings and report progress against deliverables
Support daily activities of technical and administrative staff, including training management, meeting minutes, decision logs, and organizational updates
Help manage client relationships and maintain client satisfaction
Assess cost and schedule impacts from client scope changes
Monitor budgets and schedules and prepare periodic reports
Oversee capital and maintenance projects from inception to turnover to user groups
Coordinate all technical activities on assigned projects and recognize technical issues
Support management of RFPs and approval of submittals
Oversee the work of Engineers
Lead project meetings with user groups and stakeholders
Contribute to draft proposals in response to client RFPs, including PEPs, staffing plans, schedules, cost estimates, and EV tracking tools
Identify opportunities to market services to clients and maintain ongoing client contact
Prepare detailed project cost estimates and schedules
Author proposals for small to medium sized projects (<$1M)
Lead team efforts to develop large proposals ($1M+)
Ensure proposal alignment with the cGMPnow Business Plan and brand
Document proposal status in the proprietary cGMPnow RFP Log system

What you bring

B.S. in Chemical, Biological, Biopharmaceutical, or a related engineering field
6+ years total experience in a GMP-regulated industry
4+ years in process design and engineering project management or PM support within Pharmaceutical, Biopharmaceutical, or Biotechnology sectors
Experience and working knowledge of cGMP compliance
Familiarity with FDA, EMA, and other pharmaceutical regulatory standards
Knowledge of PIC/S, ISPE Baseline & Good Practice Guides, and ASME BPE
Experience with Advanced Therapeutics Medicinal Products (ATMPs) such as autologous and allogeneic cell therapy, gene therapy, viral vectors, stem cells, mRNA, and plasmids
Experience with cGMP products including fermentors, bioreactors, mixers, pumps, chromatography, TFF, spray dryers, isolators, and vial/bag fillers
Experience with Process Gas Systems, WFI, Clean Steam Generators, Autoclaves, CIP Skids, Cleanroom HVAC, and QC laboratory equipment
Ability to apply risk assessment methodologies to projects
Capability to lead a small project or a segment of a larger project from an engineering perspective
Excellent verbal, written, and presentation skills
Strong ability to communicate and collaborate with staff at all levels
Must be eligible to work in the US without sponsorship now or in the future

Technologies and tools

Google Suite (Docs, Sheets, Slides)
BlueBeam Studio
Revit
Microsoft Office Suite (Word, Outlook, PowerPoint, Excel)

Benefits

401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Profit sharing
Charitable contributions matching

Physical requirements

Intermittent physical activity including sitting, standing, walking, bending, stooping, and crouching; occasional lifting up to 25 pounds
Ability to talk, hear, stand, sit, and type or input data using a computer and monitor for up to 8 hours per day
Normal manual dexterity and eye-hand coordination

View full job page →

1mo ago

Automation Engineer

Sofidel Circleville, OH

Circleville, OH

1mo ago Closed

Full time Electrical Engineering Automation Control Systems

This position is no longer accepting applications (closed Jul 25, 2026).

Job Description

Sofidel invites an Automation Engineer to join its manufacturing team onsite in Circleville, Ohio. The role blends project leadership with hands-on technical support, supplier collaboration, and continuous process improvements to uphold GMP and HACCP standards while prioritizing safety, quality, and cost efficiency in production. A bachelor’s degree and at least two years of relevant experience are required for this position.

Responsibilities

Support Sofidel America’s GMP and HACCP programs to maintain a safe, sanitary, and hygienically sound workplace.
Technically and economically evaluate supplier offers and prepare information to inform purchasing decisions.
Collaborate with the purchasing officer to participate in supplier negotiations when needed.
Provide technical support and training to production units, including post-startup phases.
Stay informed about technological innovations through ongoing supplier relationships.
Foster a safety-focused corporate culture and uphold corporate principles and values.
Manage Project Management activities for Capital and Major Expense projects as assigned.
Deliver practical project engineering and design expertise, completing calculations, drawings, specifications, and reports within approved schedules and budgets.
Offer technical support and direction to operations to optimize quality, efficiency, and cost.
Develop and maintain strong relationships with operations, maintenance, field service, sales, and marketing, serving as a communication channel for customer quality issues.
Identify root causes and implement corrective actions for quality and production deficiencies.
Support the production department during outages and contribute to safety improvements.
Supervise hourly technicians and co-ops in the department where applicable.
Work from verbal and written instructions and work orders; maintain open communication between shifts.
Utilize designated computer systems to input work orders, track tasks, and manage inventory parts.
Perform preventive electrical maintenance on equipment and instrument systems; troubleshoot and diagnose instrumentation or electrical failures and propose corrective actions; monitor instruments to stay within range.
Oversee and direct preventive maintenance, including contact changes, motor checks, and operation of robotic systems.
Maintain robotic systems, including all mechanical and electrical components, to ensure proper operation.
Program, troubleshoot, and repair PLC/DCS systems; repair electrical and electronic systems including electromechanical production equipment.
Collect PLC data to monitor equipment efficiency and aid in planning future conversions.
Program and monitor computerized monitoring systems to verify correct output settings.
Inspect equipment to identify potential issues; participate in process improvement efforts, identify inefficiencies and design flaws, and collaborate to resolve problems and implement improvements.
Manage contractors and vendors to improve efficiency, output, and plant safety, contributing to technology upgrades and better service.
Read and utilize electrical schematic diagrams and stay informed about new innovations and techniques in the field.
Assist with on-the-job training of other staff members.

Requirements

Bachelor's Degree in a related field; minimum 2 years of experience in an industrial environment.
Strong analytical and technical skills.
Excellent communication, documentation, and computer skills.
Solid mechanical aptitude; ability to work effectively in a team environment.
High integrity and the ability to promote a safe working environment.
Innovative with a drive for results.
Ability to manage conflict; managerial courage and interpersonal savvy are preferred.
Ability to communicate vision and purpose and motivate others is a plus.

Technologies

DVMs
Oscilloscopes
PLC
DCS
Robotic systems
Computer software applications

Other duties may include

Perform or assist with operations as required to maintain workflow and meet schedules and quality requirements; notify supervision of unusual equipment or operating problems and the need for additional materials.
Maintain a safe work area and comply with safety procedures and equipment operating rules; keep the work area clean and orderly.
Participate in meetings and work groups to integrate activities, communicate issues, obtain approvals, resolve problems, and stay informed about new developments and regulatory guidelines.
Be available to support maintenance and engineering activities outside normal business hours when needed.
Perform other related duties as assigned.

View full job page →

Gmp (good Manufacturing Practices) Engineer Jobs

Engineer V

Automation Engineer

Get Gmp (good Manufacturing Practices) Engineer Jobs alerts