Department: Azzur Austin, LLC
Drug Substance Project Engineer
Main Duties and Responsibilities:
Is the technical point of reference for pharmaceutical chemical manufacturing projects. Act as
SME for API manufacturing operations during capital projects. Responsible for design selection,
vendor management, and start-up of GMP process equipment. Will select and integrate
technologies to establish an effective API manufacturing train while managing the available
budget and scope of the capital project. Requires experience with delivering capital projects and
the technical knowledge of chemical manufacturing unit operations including reactors and filter
You will be supporting an API manufacturing expansion project based in Coppell, Texas. This
position is expected to be full time on site with potential travel and visits to design firms during
basis of design and detailed engineering phase and visits to critical suppliers for machine
assembly inspection, pre FAT, and FAT.
Chemical Engineer with experience in API operations
In-depth knowledge of API equipment including reactors and Nutsche type vacuum filter dryers.
Experience with project management.
Experience in the specification, procurement, installation, start up and commissioning of API
equipment in a licensed GMP commercial plant.
Experience with capital project delivery from business case development through project
execution and current GMP regulations.
Typical responsibilities include:
Coordinates with site cross functional team supporting the capital project including site process
SME’s, Operations lead, Validation, QA, Facilities Maintenance and Metrology.
Technical governance throughout the project lifecycle.
Lead a collaboration with site cross functional team and engineering firm to design and specify
critical technical packages including P&ID’s, URS’s and design qualifications.
Support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe
process operations and meet drug substance quality requirements.
Support procurement’s strategic supplier management efforts, establish qualified suppliers and
Working with technology leading equipment suppliers, Design Engineering and Construction
firms to successfully deliver state of the art integrated API manufacturing operations.
Providing construction phase technical audits and lead GMP equipment testing and FAT’s
including authorisation to release equipment from supplier to site.
Providing technical support to equipment commissioning and validation.
Coordinate critical technical documents reviews and approvals from engineering firm or
equipment supplier with site cross functional team and process SME’s.
Do What You Love
At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals. We take crucial steps to ensure that each employee is fulfilled both in and out of the office.
In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun.
It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.
We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.
If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands worldwide regulations and phase appropriate applications
- Draws insights from projects and supplemental research to help drive new and existing growth.
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized, solutions oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment