layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Process Engineer at Amgen

Provide system ownership for Biopharmaceutical process equipment. Identify , support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Effectively collaborate with key customers and support groups ( e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice , rules and regulations.
Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
System guidance to identify performance risks and implement risk reduction strategies.
Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.
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.
Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
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 .
Win

Bachelor’s degree in Chemical or Mechanical Engineering
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Downstream unit operations
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration 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.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience working in a regulated environment ( e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and 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
Collaborative teammate prepared to work in and embrace a team-based environment that relies on communication for effective decision-making
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
Ability for domestic/international travel (~10%)
Thrive

Senior Process Engineer

Employer job description

What you will do

Responsibilities include:

What we expect of you

Basic Qualifications:

Preferred Qualifications:

What you can expect of us

About this listing

Listing check

Similar jobs

Similar jobs