Process SME
- United States
- Contract
- CAPEX Projects
Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a Process SME to help support operations at their Maryland facility.
With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!
Responsibilities:
- Become an expert on the process and equipment to successfully lead and implement process improvements
- Develops conceptual strategies, processing schemes, feasibility studies, PFD’s, and detailed scopes of work
- Identify and execute projects to increase safety, reduce product cost, improve product quality, improve yield, and reduce material usage
- Work on several different projects and be able to prioritize these projects
- Works with contractors and project teams on buildout and expansion of facility while demonstrating confidence in voicing concerns and driving the project team to deliver a usable product for the end internal customer
- Assists in developing control strategy and instrument process design, including emergency and shutdown procedures, instrument specification sheets, control ranges, alarm points, and automation strategy
- Authors, updates, reviews, and approves area procedures and master batch records to ensure correct content and compliance with Good Manufacturing Practices
- Designs studies, executes experiments and perform data analysis
- Writes study proposals, progress reports, development reports, and various technical memo’s
- Evaluates new technologies to improve the commercial production process
- Supports scale up activities from R&D to production
- Supports the assurance of a robust manufacturing process for the current registered process as experience is gained post launch.
Requirements:
- Bachelor of Science degree in Chemical Engineering or other related technical discipline with direct chemical processing experience preferably in a pharmaceutical production environment.
- Experience within Cell-Therapy highly preferred
- Ability to read P&ID’s, Process Flow Diagrams, and perform mass and energy balances.
- Excellent verbal ,written, and interpersonal communication skills are essential.
- Displays a high desire to learn while recognizing one’s own limitations.
- Able to demonstrate technical capabilities using logical thought processes to analyze information and draw conclusions.
- Experience with bioreactors, Cell Separation Equipment, Flow Cytometers, and other Cell-Therapy equipment
- Experience with root cause investigations
- Lean certification or experience with lean concepts
If this role is of interest to you, please apply now!
#LI-NR1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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