Senior Process Engineer

Job Description

You’ll have the opportunity to work within our Life Sciences team, providing process engineering support in a pharmaceutical or biopharmaceutical manufacturing environment. You will contribute to equipment and process design, qualification, troubleshooting, automation changes, and continuous improvement while helping ensure safe and reliable site operations.

ABOUT THE JOB

Develop process designs, P&IDs, User Requirement Specifications (URS), System Risk Assessments (SRA), Functional Risk Assessments (FRA), and other engineering documentation

Participate in design reviews, design qualification activities, and HAZOP studies

Generate, review, and maintain process engineering documentation throughout its lifecycle

Support FAT, SAT, IQ, OQ, PQ, qualification, requalification, and validation activities

Lead and manage process engineering change controls, deviations, and CAPAs

Take ownership of process systems and equipment, including SIP, CIP, washers, and autoclaves

Provide independent technical support to ensure safe, reliable, and efficient site operations

Lead process and engineering improvements focused on equipment performance, yield optimization, and cycle-time reduction

Act as the link between Manufacturing Science and Technology (MS&T) and Automation teams

Translate process requirements into the required automation equipment modules, recipes, and parameters

Support recipe testing and collaborate with Automation teams to implement system changes

Lead process and engineering troubleshooting, design reviews, and optimization activities to minimize operational and supply risks

Provide on-call support for complex process issues according to operational requirements, which may include support outside regular working hours

Support lead responsibilities during absences and represent the function in delegated meetings

Provide guidance or limited oversight to assigned resources when required

Support continuous improvement initiatives and perform other responsibilities assigned by the manager

ABOUT YOU

Degree in Chemical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, or a related field

5–8 years of experience in process engineering within a pharmaceutical, biopharmaceutical, biotechnology, or similarly regulated manufacturing environment.

You have experience with process design, P&ID development, URS, risk assessments, design reviews, and HAZOP

You understand qualification and validation activities, including FAT, SAT, IQ, OQ, PQ, and requalification

You have practical knowledge of CIP, SIP, washers, autoclaves, or comparable pharmaceutical process systems

You are experienced in managing change controls, deviations, investigations, and CAPAs

You understand automated manufacturing processes, including equipment modules, recipes, and process parameters

You can collaborate effectively with MS&T, Automation, Manufacturing, Quality, Validation, and Engineering teams

You demonstrate strong troubleshooting, analytical, documentation, and problem-solving skills

You can work independently, propose practical solutions, and assume lead responsibilities when required

You are available to provide on-call technical support according to operational needs

#J-18808-Ljbffr