Process Engineer

Job Title: Process Engineer Validation and Risk Management

Location: Kennebunk, ME04043

Duration: 06 Months

Job Description:

Purpose of Position:

Candidate will apply process and regulatory compliance knowledge to lead and support new and retrospective products through development of risk assessment and validation protocols. The deliverables of these efforts will be used to support regulatory compliance, process development and improvement of direct and indirect manufacturing procedures. Role will work with subject matter experts to establish and document standard practices and procedures. Encompasses the application of scientific and technological principles concerned with a continuous or periodic system of operations or activities in the production of manufactured products. This position works closely with operations management, functional leaders, engineers, and external partners to establish work priorities and work assignments across the various functional groups. Support the development and execution of plans to evaluate new technologies or improvements in existing technology and infrastructure resulting in a superior product and process in terms of quality and cost.

Major Roles and Responsibilities:

Actively collaborate with other site Quality, Operations, Engineering personnel, and suppliers to establish, maintain and improve methodologies.

Provides technical leadership in assigned processes.

Act to continuously improve overall plant performance through project identification and completion.

Lead standardization efforts in assigned processes.

Ensure consistency by all site functional groups to standard processes, business and quality systems, and governmental regulations (OSHA, ISO 13485, QSR, FDA, GMP, etc.).

Support the Quality, Operations and Engineering teams in process control and discipline through development, revision and release of controlled documentation.

Lead and execute experimentation plans. •Write technical reports for completed experiments.

Implements and documents material, process and/or equipment changes through proper change management.

Functions as a team member or team leader on focused projects

Supports new product introductions through equipment installation, process certification, documentation and training.

Education: BS in Engineering or similar: (Mechanical, Electrical, Manufacturing, Chemical, Quality, Process, etc.)

Experience:

Minimum of 2 years’ experience in a process engineering, quality or technical role in a manufacturing environment.

Top Skills Required

Proven/Solid ability to develop and lead the completion of risk assessments in controlled formats such as PFMEA as well as leading drafting and implementation of PFMEA risk assessment.

Experience in leading the drafting and implementation of IQ, OQ, PQ format Validations.

Ability to author validation protocols in with statistical justification for custom manufacturing equipment using the product specifications and risk assessments.

Familiarity with engineering tools and approaches: DOE, SPC, Data Analysis, DMAIC, etc.

Be interested in working for Client, if presented with a full-time job opportunity.

Be willing to work at the posted job location.

Required Skills:

Computer literacy (Microsoft Office suite.)

Problem-solving and Risk Based Assessment skills.

Organizational and Time Management skills.

Ability to build relationships and interact with all levels of the organization.

Excellent verbal and written communication skills; ability to effectively present information.

Results-oriented.

High initiative, able to work independently, and in a team environment.

Flexibility - Able to change and adjust smoothly as the situation demands.

Strong working knowledge of MS Excel, including formulas and graphing functions.

Demonstrated leadership or strong teamwork in accomplishing common goals.

Soft Skills:

We are looking for you to perform in a fast-paced, dynamic environment and have demonstrated skills working with multi-functional teams to identify root causes and solve complex process issues. You should have the ability to clearly and frequently communicate ideas and progress against objectives.

Strong social and communication skills – effective at interacting and communicating across functional departments and varying organization levels.

Technical curiosity and willingness to learn.