United States, Portsmouth (New Hampshire)
The MES Engineer/Process Recipe Author will work on developing new Electronic Batch Records (eBRs) and revising existing eBRs using a library of existing work instructions and operations. Position is expected to operate with some supervision and some autonomy.
Key Accountabilities and Duties:
- Develop new electronic batch records (eBRs) and revising existing eBRs using a library of existing work instructions and operations.
- Work with RA supervisor to monitor progress against a known schedule.
- Create new electronic workflows as assigned. Incorporate identified changes from recipe review process.
- Execute protocols for testing and validation of eBRs, operations and electronic work instructions.
- Assist senior staff in the execution of Process Change Controls and responses to CAPAs (Corrective and Preventative Actions).
- Conduct troubleshooting on eBRs and Syncade development environment.
- Support the approval and roll out of new/revised SOPs as part of paper BRs to eBRs conversion and any ongoing process improvements.
- Off-hours coverage and support responsibility via a rotating schedule.
- Bachelor’s Degree required. Preferred area of study in Engineer, Biology, Chemistry or similar.
- Excellent communication, client consulting, and project management skills.
- A core background in either Life Sciences Manufacturing or MES (Manufacturing Execution Systems) with complementary skills in the other. Preferred experience in an IT Engineering role supporting manufacturing or related industry.
- Background in implementing or software engineering for MES systems (ex.- weigh and dispense, EBR, integration), preferably in a regulated or pharmaceutical production environment.
- Understanding of TrackWise, SAP, and LIMS.
- Experience with automated systems desired (Delta V Preferred).
- Hard working, inquisitive, mentally-flexible and critical thinking are must have qualities for the role.
- Ability to maintain a professional demeanor at all times.
- A positive attitude and an ability to adapt to, and embrace changed conditions are a big plus.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if it is not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.