What are the responsibilities and job description for the Senior Process Engineer - Contamination Control Specialist position at INCOG BioPharma Services?
We invite you to join our growing team!
Are you an experienced process engineer looking for an exciting opportunity with an organization where you can have an impact on global health and wellness?
We are looking for a Senior Process Engineer who will help with our growth. Do you naturally create new ways to deliver exceptional results? We want to meet you!
INCOG’s Why: Patient Impact
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, we are more than just a contract development and manufacturing organization. We are a company born out of a simple idea—that there has to be a better way. A better way to work with our customers. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.
Join us in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, our clients, and patients.
Working at INCOG
We VALUE excellence, innovation, accountability, partnership, transparency, and results. We strive to be different putting our team at the forefront of everything we do and every decision we make. At INCOG, we are actively creating a culture where our team members are encouraged to be innovative, service-oriented, and collaborative problem solvers who are dedicated to meeting the challenges of working at a high-growth company. We are committed to empowering our employees to be their best and to making INCOG a rewarding and fun place to work.
We truly believe that every employee contributes to the success of the company, and you can be part of that team.
Our Values (ALP)
All IN
The Senior Process Engineer will provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors.
Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.
Essential Job Functions
Are you an experienced process engineer looking for an exciting opportunity with an organization where you can have an impact on global health and wellness?
We are looking for a Senior Process Engineer who will help with our growth. Do you naturally create new ways to deliver exceptional results? We want to meet you!
INCOG’s Why: Patient Impact
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, we are more than just a contract development and manufacturing organization. We are a company born out of a simple idea—that there has to be a better way. A better way to work with our customers. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.
Join us in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, our clients, and patients.
Working at INCOG
We VALUE excellence, innovation, accountability, partnership, transparency, and results. We strive to be different putting our team at the forefront of everything we do and every decision we make. At INCOG, we are actively creating a culture where our team members are encouraged to be innovative, service-oriented, and collaborative problem solvers who are dedicated to meeting the challenges of working at a high-growth company. We are committed to empowering our employees to be their best and to making INCOG a rewarding and fun place to work.
We truly believe that every employee contributes to the success of the company, and you can be part of that team.
Our Values (ALP)
All IN
- Patient Impact
- Bring a positive attitude and best efforts, every day
- Company commits to your growth and success, professional and personal
- Have a bias for action
- Be service-centric and solution-oriented
- Welcome challenging projects and timelines
- Work to be flexible with well designed systems and protocols
- Our customers’ success comes first
- Treat others with respect; help rather than criticize
- Celebrate the wins!
The Senior Process Engineer will provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors.
Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.
Essential Job Functions
- Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
- Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- Mentor and train other team members.
- Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
- Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
- Participate and report to a cross-functional team to advance production activities.
- Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
- Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)
- Execute engineering studies, recipe development, and validation test cases.
- Work with vendors and suppliers to define requirements and understand functional specifications.
- Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.
- Work flexible hours for the coverage of the production facility.
- Sterile Injectables (Formulation, aseptic filling, inspection, and/or packaging)
- Knowledge of data management tools and RCM.
- Bachelor’s degree or higher in engineering, bioengineering, or related scientific field.
- 5 years’ experience in biopharmaceutical or other GXP regulated industry.
- CMO/CDMO experience
- Technical and/or lean six sigma certifications
- Electro-mechanical practical experience
- Paid vacation days, amount based on tenure, and paid sick time
- 11 observed holidays
- 401(k) plan with company match up to 3.5% of salary, vested immediately
- Choice of health & wellness plans
- FSA and HSA programs
- Dental & vision care
