Process Engineer IV

Process Engineer IV

DIRECT HIRE OPPORTUNITY

M-F 8am-5pm

Salary/benefits:
*Up to $120k
*5% annual bonus target
*PTO, insurance, 401k match, etc.
*Relocation assistance if needed

Orion Group is now looking for a Process Engineer for a direct hire role for our intravenous medical device manufacturer in Austin, TX.

The Process Engineer completes advanced engineering projects with peer input and guidance from engineering management to increase yield, maximize capacity, reduce costs, and decrease process variability, while maintaining regulatory compliance.

The Process Engineer should be a specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group.

Process Engineer Responsibilities

* Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions.

* Plans, organizes and conducts technical projects.

* Consolidates results of design elements of major projects for purpose of design review.

* Integrates subsystems and components in total systems design.

* Develops specifications from customer requirements.

* Receives general project direction. Responsible for project progress.

* Decisions consistently affect multiple or critical projects in the business and may impact external relationships.

* Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

* Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus

* Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.

* May routinely monitor or supervise the work of one or more employees.

* Provides input on performance evaluations to area manager.

* Identifies opportunities, develops insights, stimulates new ideas, and implements process improvements in collaboration with manufacturing, engineering, other essential internal partners, and external partners including vendors and project contract support.

* Assists with technically challenging process deviations and their resolution.

* Provides direct support to all commercial pharmaceutical manufacturing and support operations by supplying direct technical expertise and advanced statistical concepts e.g. DOE with focus on process capability and reliability.

* Provide direct project management support including planning, securing funding, technical support to Validation Coordinator, and oversight and guidance to project support organizations.

* Participate in start-up efforts of new equipment, software, or processes.

* Implement changes using GMP change control and validation processes.

* Previewing/providing feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc.

* Collaborate with center functions on product development initiatives.

* Work on special projects as they arise

Process Engineer Qualifications

* Has mastered best practices.

* Has an advanced understanding of engineering discipline

* Can assess what work supports the product strategy and make insightful recommendations regarding priorities

* Expert in your domain of expertise.

* Familiar in other areas of domain expertise within the team.

* A masters or PhD is required. Preferred specialties are: Mechanical, Chemical, Industrial, or Biomedical engineering.
*7+ years' experience with a master's degree or 5 years' experience with a PhD

*Chemical engineers are most ideal but will consider other specialties

*Experience in pharma, biotech or other similar industries required

Minimum Qualifications
* Must be at least 18 years of age

Travel Requirements
* Typically requires travel less than 5% of the time

Physical Requirements and Work Environment
* This is largely a sedentary role.
* This job operates in a professional office environment and routinely uses standard office equipment with occasional work performed in a clean room environment
* While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
* Must be able to occasionally move and lift objects of up to 25 lbs

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.