Process Engineer II

Planet Pharma; Minneapolis (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Planet Pharma seeks a technical specialist for process development and manufacturing readiness, focusing on qualification activities (IQ/OQ/PQ) and line validation. The role supports development and production manufacturing readiness for coated medical devices in a regulated environment.

Ideal candidate has 2–5 years of experience in process development, with strong knowledge of process characterization and equipment development.

Qualifications

• Requires practical knowledge in process development with IQ/OQ/PQ experience.
• Experience with equipment development and process characterization preferred.
• 2–5 years of experience in process development and related deliverables.

Responsibilities

• Focus on process qualification activities, process improvement activities, and manufacturing line validation activities.
• Provide technical and sustaining engineering support in a manufacturing area; recommend equipment and process modifications to meet quality standards and improve production efficiencies.
• Integrate equipment and material capabilities to meet target specifications and review product development requirements for processing compatibility.
• Interact with design and development personnel to ensure processes and designs are compatible; may conduct statistical analysis or suggest document enhancements.
• Lead innovation and optimization of manufacturing concepts, processes, and procedures for transfer to manufacturing operations; support SPC and measurement systems.

Skills

Engineering tools knowledge

Goal oriented

Solutions driven

Education

Bachelor's degree

Job description

Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?

1. Knowledge of engineering tools utilized in Process development, Goal oriented, and solutions driven.

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

1. This role will focus on process qualification activities, process improvement activities, and manufacturing line validation activities.

What products (if any) will this role support?

1. This role will focus on development and production manufacturing readiness activities on pharmaceutical coated medical devices

What is your target years of experience?

1. 2 – 5 years of experience

Relevant experience in process development deliverables (IQ, OQ, PQ), process characterization work, and equipment development experience is preferred.

Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation – while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects & assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 2 years of relevant experience, or advanced degree