Company Overview:
Founded in 1999, Asymchem is a globally integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener,and more cost-effective manufacturing to support clinical research and commercialization. Asymchem currently operates eight manufacturing facilities offering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations, and clinical research services. Asymchem Group, headquartered in Tianjin, P. R. China.
The Asymchem Sandwich site focuses on drug substance development and transfer of these early-stage processes into manufacturing within the Product Development Facility (PDF) in support of clinical and small scale commercial manufacturing.
Job Overview:
The Senior Process Engineer is a role in the manufacturing team in Sandwich. This position manages the delivery of new equipment/technology via continuous improvement as part of the site capital projects program. It provides process safety support to ensure the facilities manufacturing processes are capable of meeting the processing demands of the latest generation of Drug Substance Targets and their intermediates.
Duties & Responsibilities:
* Provides process engineering support to the PDF to ensure it meets operational requirements and all applicable legislative and corporate standards. Complies with all aspects of current Good Manufacturing Practices.
* Supports the ongoing capital development of operations and process facilities by defining and clearly specifying requirements, and then collaborating with external vendors, facilities, and engineering groups to deliver and implement the appropriate design solution.
* Project manage and provide technical expertise to capital projects from initial conceptual design, through detailed design, installation, and commissioning/validation. Ensure that projects are completed on schedule and to budget following all applicable corporate and regulatory guidance/requirements.
* Leads the definition of validation requirements and standards including writing, review and technical assessment of validation protocols, commissioning and start up.
* Leads specialist safety reviews and Process Hazard Assessments (PHA) including What-If evaluations, HAZOP, LOPA, and Failure Mode & Effects Assessments, when required.
* Provides process safety engineering support to the PDF to meet Operational requirements & applicable Legislative and Corporate standards.
* Reviews changes for technical accuracy and applicability to ensure the proposed change meets operational requirements while adhering to Good Engineering Practice and EHS/Quality requirements as required.
* Provide expertise to the Pilot Plant or Laboratories by bringing knowledge of chemical engineering concepts and techniques to solve practical development and plant operational problems.
* Leads or participates in Quality and Safety investigations.
* All other duties as assigned.
Essential Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
* Degree in Chemical Engineering, Pharmaceutical Engineering, or related engineering discipline. (BEng, MEng, BSc)
* Minimum of 5 Years relevant experience within a manufacturing environment.
* Competent in equipment specification, purchase, and related tasks.
* Experience in HAZOP, LOPA, and process safety analysis.
* Capable of writing and reviewing commissioning or validation protocols and technical documents.
* Strong communication, teamwork, and adaptability skills.
Desirable Experience Requirements
* Experience in the delivery of capital projects within a pharmaceutical environment or similar industry such as Chemical or FMCG.
* Knowledge of chemical engineering principles applied to drug substance manufacturing.
* Experienced in leading Process Safety technical discussions.
* An understanding of engineering controls required to manage high potency compounds.