Position Summary:
We’re seeking a seasoned process engineer with deep expertise in both wet and dry granulation to support design, installation, qualification, and ongoing optimization of our granulation operations. The ideal candidate will have at least five years of hands-on experience with high-shear wet granulation (Glatt) and spray-drying processes, strong troubleshooting skills, and a solid background in compliance documentation and change-control activities.
Granulation Expertise:
Lead high-shear wet granulation (Glatt) and spray-drying operations.
Troubleshoot process deviations and implement robust corrective actions.
Commissioning & Qualification:
Support design reviews, installation activities, and qualification (IQ/OQ/PQ).
Review, approve, and resolve issues in C&Q documentation.
Facilitate change-control step-closure and discrepancy resolution.
Documentation & Compliance:
Develop, review, and approve SOPs, work instructions (WI), and LOTO procedures.
Perform machine-guarding, dust-explosion, and ergonomic risk assessments.
Coordinate spare-parts evaluation and maintenance-strategy planning in partnership with reliability engineering.
Technical Reviews:
Review and approve P&IDs, process drawings, and utility schematics.
Identify special equipment needs (carts, modifications, procurement).
Training & Support:
Create and deliver process schools for operators and technical teams.
Provide ongoing technical support to manufacturing and maintenance staff.
Cross-Functional Collaboration:
Partner with Reliability, Quality, and Engineering teams to optimize equipment life-cycle and reliability.
Interface with contractors and vendors during installation, start-up, and maintenance phases.
Bachelor’s degree in Chemical Engineering or related engineering discipline.
Minimum of 5 years’ direct experience in high-shear wet granulation (Glatt) and spray-drying.
Proven track record supporting C&Q activities in a regulated manufacturing environment.
Strong understanding of GMP, cGMP, and safety regulations (machine-guarding, dust-explosion prevention).
Excellent technical writing skills and proficiency with CAPA/change-control systems.
Demonstrated ability to analyze complex processes and lead troubleshooting efforts.
Experience in pharmaceutical or biotechnology manufacturing.
Hands-on familiarity with P&ID development and revision control.
Prior involvement in equipment procurement and modification projects.
Training or certification in Lean, Six Sigma, or other process-improvement methodologies.
Strong interpersonal skills with capacity to train and mentor junior engineers and operators.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*