Project Equipment Engineer

About PSC Biotech

Who we are

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Project Equipment Engineer

Job Description:

The Project / Equipment Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation Component Preparation Vial/Syringe Filling Lyophilisation Device Assembly Inspection Labelling and Packaging areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.

Requirements

Key Responsibilities:

Project management and execution of assigned projects including project prioritization resources management status management and external communication.

Working with various stakeholders to scope projects and ensure requirements are satisfied. Project input will span from concept through design construction commissioning and operation.

Coordinating the introduction of new processes equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & startup

Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.

Ability to translate strategic/emerging technology solutions into pragmatic executable plans.

Development and management of change controls

Participate as a member of multidisciplinary site and multisite teams.

Development of detailed specifications engineering documents protocols and standard operating procedures

Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.

Works in a collaborative manner with the System Owners Maintenance Supervisors & Technicians Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.

Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements policies and procedures.

Support a safe working environment by complying with environmental health/safety practice rules and regulations.

Travel may be required to support execution of projects.

Experience and Qualification:

Bachelor s degree in engineering (Mechanical Electrical or Chemical) or Relevant Experience

Typically 3 years engineering experience preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly Labelling and Ancillary processes.

Proven project management experience.

Strong mechanical capability with hands on experience in a technical role within a highvolume manufacturing environment is advantageous.

Demonstrated experience in a GDP Compliant environment.

Experience in MS Office MS Project Change Control & Document Management Systems

Proven ability working cross functionally delivering technical solutions and implementing improvements.

Solid leadership skillset and experience working in a team environment embracing an interdependent working culture that delivers results.

Technical report writing and communication/presentation skills.

Data driven decision maker.

Ability to work to tight deadlines in a fastmoving environment.

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