Position:
Job Overview
The role involves providing process technology support at customer locations, including process validation, scale-up/scale-down, process optimization, product trials and troubleshooting of pharmaceutical OSD equipment and processes.
Key Responsibilities
- Perform
PQ / Exhibit / Process Validation
at customer locations, including scale-up/scale-down calculations. - Conduct
process and product optimization
and process improvement activities. - Conduct product trials on
R&D laboratory machines
. - Prepare process proposals and value propositions for
machines
. - Identify and resolve machine/process-related challenges in coordination with cross-functional teams.
- Conduct training for internal and external stakeholders on:
- Scale-up/scale-down
- Process optimization
- Machine functions and operations
- Psychrometry
- Prepare and publish detailed
process reports
after customer visits. - Coordinate with Regional Service Engineers to resolve machine and automation-related issues.
- Coordinate with Regional Sales Heads for process-support requirements in the assigned region.
- Develop and regularly update databases for products/processes running on machines.
- Conduct process studies for new customer requirements and prepare value propositions.
- Attend monthly review meetings at the
Pune office
to review process achievements and open issues. - Share learnings, new ideas and experiences during monthly meetings.
- Implement
CAPA
wherever changes are required in machines for optimum process output. - Obtain regular customer feedback and report updates to the reporting manager.
- Prepare and submit weekly and monthly visit summary reports.
Mandatory Technical Experience
- Experience in
Formulation Development and Technology Transfer
. - Strong hands-on experience in:
- Granulation
- Fluid Bed Processing
- Tablet Coating
- Blending
- Hands-on experience in handling and troubleshooting various
OSD pharmaceutical machines and formulations
. - Experience in
palletization and tablet coating technology
. - Knowledge of various
granulation technologies and blenders
. - Exposure to
Hot Melt Technology
and Powder Laying Technology
. - Strong understanding of
scale-up/scale-down calculations and philosophy
for various OSD equipment. - Understanding of
productivity enhancement tools
. - Good knowledge of
21 CFR, cGMP and pharmaceutical documentation
. - Understanding of
psychrometry
.
Desired Skills
- Excellent verbal and written communication skills in English and the local language.
- Good presentation and training skills.
- Strong problem-solving and analytical abilities.
- Adaptability and leadership skills.
- Attention to detail.
- Ability to think creatively and develop practical solutions.
- Willingness to travel extensively, with
minimum 70% travel to customer locations
.
