Principal Process Engineer UpstreamDownstream

Principal Process Engineer - Upstream/Downstream

What you will do

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design build commission and qualify new equipment and systems needed for drug substance production. You will lead technical projects and drive innovation in product design and manufacturing processes. You will solve complex engineering problems optimize processes and ensure the companys engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

• Site design construction start-up and operational readiness:

• Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements including equipment design and sizing architecture and electrical distribution and piping and instrumentation diagrams.

• Support factory acceptance testing working in partnership with global engineering during site installation including reviewing protocols and resolving punch list items.

• Work with capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice rules and regulations as well as Amgen global engineering requirements. Ensure that systems are installed per the design requirements.

• Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed.

• Perform engineering assessments for plant equipment operations implementing equipment modifications and supporting engineering runs in support of new product/technology introductions as .

• Site Operations:

• Provide system ownership for Upstream and/or Downstream Drug substance process equipment areas and systems providing end-to-end support for operations.

• Serve as a main point of contact for Process and equipment engineering function.

• Effectively collaborate with key customers and support groups (e.g. Manufacturing Quality Process Development Maintenance network partners) to ensure reliable plant operations.

• Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable.

• Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements identifying design requirements and translating these requirements into process equipment/system design specifications and supporting the construction startup and validation of equipment.

• Develop master maintenance programs for equipment ensure the availability of spare parts and coordinate maintenance activities to ensure systems are in proper working order.

• Ensure plant readiness and quality and regulatory compliance for internal audits external agency audits and partner audits for the process equipment.

• Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.

• Lead new product/technology introductions by performing engineering assessments equipment performance risk assessments identifying gaps and owning their remediation implementing equipment modifications and supporting engineering runs.

• Provide mentorship and coaching to junior engineering peers when they encounter challenges and roadblocks as appropriate.

• Demonstrate knowledge and understanding of how building and process automation systems interact with and impact process equipment and be able to effectively communicate automation issues and needs to support groups and to management.

• Effectively communicate the correct level of detail for process risks in a timely manner to support groups and leadership.

• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.

• Up to 10% domestic/international travel.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of engineering experience

OR

• Masters degree and 4 years of engineering experience

OR

• Bachelors degree and 6 years of engineering experience

OR

• Associates degree and 10 years of engineering experience

Or

• High school diploma / GED and 12 years of engineering experience

And

• 2 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources

Preferred Qualifications:

• Bachelors degree in Chemical or Mechanical Engineering or related technical field..

• 8 years of relevant work experience with 5 years experience in Biopharmaceutical operations/manufacturing environment focused on process and plant engineering function.

• Demonstrated people and/or project management and leadership experience.

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Upstream and Downstream purification equipment such as cell culture reactors centrifugation chromatography viral filtration skids and UFDF skids as well as other equipment needed to support these processes such as autoclaves clean in place (CIP) systems washers clean steam water for injection etc.

• Experience with designing and operating equipment used in biopharmaceutical manufacturing.

• Experience with Tech Transfer Process Design and Commissioning & Qualification.

• Experience working in a regulated environment (e.g. cGMP OSHA EPA etc.) and with GMP quality systems/processes such as change control non-conformances corrective and preventative actions and qualifications/validation

• Understanding of safety requirements working in a GMP Biopharmaceutical production facility.

• Independent ambitious organized able to multi-task in project environments and skilled in communication facilitation and teamwork.

• Strong leadership technical writing and communication/presentation skills

• Work schedule flexibility as to support 24/7 operations.

• Ability for domestic/international travel.