Manufacturing Engineer II

Planet Pharma; Irvine (CA); On-site; USD 66,000 - 80,000; Full time

Job summary

Planet Pharma seeks a senior-level manufacturing engineer contractor to own two high-priority workstreams: validating a highly customized oven-like equipment and managing an external vendor through the design and implementation of a new system. This role blends hands-on engineering judgment with delivery leadership in a less standardized environment.

Strong project management and vendor coordination are essential to drive end-to-end validation and ensure milestones are met while maintaining

Qualifications

• Senior-level engineering contractor with hands-on validation experience.
• Experience validating ovens and thermal systems.
• Strong project management discipline for cross-functional workstreams.
• Vendor management experience and ability to coordinate external deliverables.
• Comfort working in less standardized environments with non-standard equipment.

Responsibilities

• Study time, motion, methods, and speed to improve efficiency.
• Interpret drawings and schematics to determine quality standards.
• Read logs and specs to verify QA adherence.
• Plan work assignments based on performance and schedules.
• Prepare charts/diagrams for workflow, floor layouts, and utilization.
• Observe equipment usage to verify QA adherence.
• Evaluate data and write deviation reports.
• Lead Equipment Validation for customized systems.
• Manage external vendor through design and implementation of a new system.
• Define validation scope and success criteria.
• Coordinate project and vendor activities end-to-end.
• Oversee deployment of the resulting system and ensure milestones are met.
• Maintain parallel progress of both workstreams.

Skills

Creativity

Verbal and written communication

Analytical and problem solving

Team player

Detail oriented

Engineering drawings

Blueprint reading

CAD

Education

Bachelor’s degree in engineering

Tools

CAD

Job description

Target PR Range: 48-58/hr DOE

Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints. We are seeking a senior‑level engineering contractor to own two high‑priority workstreams: validating a highly customized piece of equipment (essentially a large, custom oven) and managing an external vendor through the design and implementation of an entirely new system. This is not a narrowly technical role — it combines hands‑on engineering judgment with coordination and delivery leadership.

Job Responsibilities:

• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
• Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
• Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
• Evaluate data and write reports to validate or indicate deviations from existing standards.
• Equipment Validation
• Lead formal qualification and validation of a highly customized mechanical/thermal equipment system.
• Apply structured validation discipline to non‑standard, custom‑built machinery with moving parts and heat‑related operating conditions.
• Independently define validation scope, approach, and success criteria for equipment whose risk profile spans performance consistency, safety, and process reliability.
• Project & Vendor Management
• Act as the company‑side lead coordinating an outside vendor through the design of a new system.
• Translate internal expectations into executable vendor deliverables and drive accountability throughout the engagement.
• Oversee implementation and deployment of the resulting system, not just design discussions.
• Keep workstreams on track across technical and external stakeholders.

Skills:

• Creativity, verbal and written communication skills, analytical and problem‑solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer‑generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Required Qualifications:

• Senior‑level engineering contractor experience with a demonstrated ability to step in quickly and operate with minimal ramp‑up.
• Hands‑on equipment validation experience, particularly with machinery involving:
• Ovens and thermal systems
• Motors and rotating equipment
• Custom or complex electromechanical machinery
• Strong project management discipline — ability to plan, coordinate, and drive cross‑functional workstreams to completion.
• Vendor management experience — proven track record of managing third‑party vendors, driving accountability, and bridging internal expectations with external deliverables.
• Comfort working in less standardized environments where equipment is not off‑the‑shelf and validation approaches must be adapted.

Ideal Candidate Profile:

• Can independently structure and drive a validation effort from ambiguity to execution.
• Brings practical breadth across mechanical, rotating, and heat‑based systems — not limited to purely software, documentation‑only, or narrowly regulated validation work.
• Operates with enough seniority to manage ambiguity, push external partners, and bridge engineering execution with delivery management.
• Reduces the burden on the internal team by absorbing ownership and creating structure.

What Success Looks Like:

• The custom equipment is validated and qualified with clear, defensible results.
• The vendor‑driven system design progresses on schedule with accountable deliverables.
• Internal stakeholders have reduced management overhead because the contractor owns coordination end‑to‑end.
• Both workstreams move forward in parallel without one blocking the other.

Education/Experience:

• Bachelor’s degree in engineering required.
• 5-7 years’ experience required.