Search Jobs
Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.planet-pharma.com
https://www.planet-pharma.com
true
Principal Automation Engineer
Posted: 06/04/2025
2025-06-04
2025-07-12
Employment Type:
Contract
Job Category: Engineering
Job Number: 619654
Is job remote?: No
Country: United States
Job Description
Target PR Range: 47-57/hr
*Depending on experience
The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4–5 years of direct, hands-on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V.
Candidates should ideally hold a Bachelor’s degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). However, substantial practical Delta V experience can outweigh formal educational qualifications. A strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams. Experience in PLC systems and Delta V system administration is beneficial but not mandatory. Candidates must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long-term roles.
Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Responsibilities:
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
Skills:
- BS in Engineering and previous experience in a medical device industry
- 10 years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical medical devices.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in drug/device combination product design and development
- Familiar with the following standards:
o Quality System Regulation? 21CFR820
o Risk Management? ISO 14971
o EU Medical Device requirements? Council Directive 93/42/EEC
o Medical Electrical Equipment? EN 60601
- Small scale device assembly experience.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!
*Depending on experience
The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4–5 years of direct, hands-on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V.
Candidates should ideally hold a Bachelor’s degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). However, substantial practical Delta V experience can outweigh formal educational qualifications. A strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams. Experience in PLC systems and Delta V system administration is beneficial but not mandatory. Candidates must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long-term roles.
Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Responsibilities:
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
Skills:
- BS in Engineering and previous experience in a medical device industry
- 10 years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical medical devices.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in drug/device combination product design and development
- Familiar with the following standards:
o Quality System Regulation? 21CFR820
o Risk Management? ISO 14971
o EU Medical Device requirements? Council Directive 93/42/EEC
o Medical Electrical Equipment? EN 60601
- Small scale device assembly experience.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
Share This Job:
Related Jobs:
There are currently no related jobs. Please sign up for Job Alerts.
Loading...
Login to save this search and get notified of similar positions.
About Thousand Oaks, CA
Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.