Project 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 cloud-based 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 like-minded 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 diverse-cultural work setting.

Employee Value Proposition
Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house 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.

Description:

Project Engineer / Cell Engineer

Job Purpose:

• Provide engineering support in developing new or improving existing equipment and/or process related activities.
  
• Define or assist in defining process equipment requirements and specifications based on process requirements, client safety requirements and customer needs.
  

Responsibilities:

Main areas of responsibility:

Perform project management tasks for small to medium scale projects involving either new or existing equipment.

Assist in determining the budget to support requirements.

Evaluate or assist in evaluating technology necessary to support requirements.

Propose options to Management/Customer/Stakeholders.

Provide technical support for projects.

Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes and procedures.

Assist in negotiation with equipment suppliers.

Utilize necessary project tools, i.e. URS, Microsoft Project, etc. to manage projects successfully.

Develop the necessary equipment, process and product knowledge to be recognised as a local expert.

Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements.

Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs.

Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.

Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.

Ensure effective closure on quality system documents (Audit Action, NCR s, CAPA s, Maps, etc.).

Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.

Requirements

Education and Experience Required for Role:

Essential:

Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.

Desirable:

4 years experience in relevant engineering role

Prior experience in a GMP or medical device manufacturing environment

Prior experience in equipment and process validation activities

Process development experience

Familiar with ISO safety standards

Previous experience in the use of black belt statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment

Have statistical process control and capability analysis using ANOVA and DOE techniques

Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement.

Other Skills and Attributes:

Develop good working relationships across the business

Ability to motivate and lead - must be team orientated

Ability to work on own initiative

Good project management and communication skills.

Attention to detail

#LI-FP1

Education and Experience Required for Role: Essential: Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering. Desirable: 4 years experience in relevant engineering role Prior experience in a GMP or medical device manufacturing environment Prior experience in equipment and process validation activities Process development experience Familiar with ISO safety standards Previous experience in the use of black belt statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment Have statistical process control and capability analysis using ANOVA and DOE techniques Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement. Other Skills and Attributes: Develop good working relationships across the business Ability to motivate and lead - must be team orientated Ability to work on own initiative Good project management and communication skills. Attention to detail #LI-FP1