About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.
Be BOLD (Find a Way)
Care Deeply – for our patients, each other and our work
#GSD (Get Stuff Done)
What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.
The Project Engineer II will perform engineering design evaluations and works to complete projects within budget and scheduling constraints. The Project Engineer II supports capital projects: conceptualize solutions, define budgetary scope, gain approval for capital funding, forecast spending, accrue financials, coordinate schedules, startup projects and obtain approval of installations. The Project Engineer II will assure capital projects are within +/- 10% of projected costs, on time and of high quality utilizing fundamental skills of budget forecasting, risk management and project management. Additionally, the Project Engineer II provides technical support to other functions, helps resolve operational problems, and communicates operational plans for completing projects. This role coordinates with cross-functional departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Facilities.
Manage projects of small and medium scale to ensure project is executed within time, cost and budget constraints
Develop engineering scope of work for design firms or contractors
Develop User Requirement Specifications (URS) with Subject Matter Experts (SME’s)
Review of engineering design documents from design firms or contractors
Fully reviews drawings & specifications in preparation of subcontractor scope
Read and generate documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS)
Reviews submittals for conformance to contract documents and tracks submittal process
Maintains and updates purchasing schedule and submittal log
Maintains & assists project manager with preparation of weekly project update accurately and on time
Engage with EHS vendors/contractors as needed to initiate, develop, and/or renew contracts and service obligations
Bachelor’s degree in engineering
5 years of professional cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture (biopharma preferred)
Experience in writing equipment protocols and change controls
Ability to lead and manage projects with attention to detail and prioritization, working cross-functionally and on appointed teams, and managing external trades
Experience in contract administration and working with outside vendors
Strong interpersonal, written, and verbal communication skills
Strong reasoning and analytical skills
Strong computer skills working with standard MS Office suite applications and experience with metrics and reporting
Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
BS Mechanical/Chemical/Electrical Engineering
Familiarity with filling technology, RABS and Isolator technologies, sanitization, filling systems, particle counter
Commissioning, qualification, start-up and operational readiness experience within a pharmaceutical GMP manufacturing environment
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20 lbs.
This is an on-site role working in a cGMP regulated manufacturing facility.
On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Sandford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans