- Reference: 41494
- Job Type: Permanent
- Location: Offaly, Roscommon, Westmeath
- Category: Engineering, Technical & Manufacturing
Job Title: Lead Process Engineer
Working with the Process Development Group
Liases and works closed with the Technical team.
Type : Permanet role
i) execution and analysis of various study designs required to fully explore the functional relationship between process parameters/set-up and product characteristics – positioning final selected commercial processes in an optimal region of the space defined,
ii) optimise processes for validation and routine commercial production,
iii) leading Technician & Associate teams in establishing appropriate processing and cleaning practices to support CMC development, Validation and Commercialisation (including Classified area processing),
iv) execute re set-up, technical support and monitoring of Project related CMO’s.
As product(s) progress through Validation to Commercial Manufacturing, this position may transfer to Manufacturing with the technical team to manage ongoing routine commercial supply of product(s). Whilst this resource resides within the PD group additional proprietary project or functional development responsibilities may also be assigned. Specifically all the afore mentioned responsibilities will cover at minimum the following:
•Prepare and execute experimental programs, for use in formulation/process development activities, involving investigational studies to provide indicative process/analytical data for formulation selection and identification of critical process parameter effects. Analyse the process and analytical data generated by these programs and report on same.
•Design and lead process development activities focused on study of critical parameters to ensure that process conditions, at all scales, are consistent and not at “edge of failure”. Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved.
•Develop, execute and refine the methodology required for the generation of successful scale-up/optimisation process models. These models are required to accurately establish process operating windows at relevant scale and identify appropriate in-process operating ranges to maintain both product quality and production efficiency.
•Manage execution of project activities, from development through launch, associated with new formulation product / Technology development programs.
•Prepare, execute, analyse and control all Process Development documentation required during related development/scale-up activities.
•Maintain current understanding of the state of new/existing technologies through frequent communications to and periodic training at relevant industry/institute sites.
•Analyse and provide resolution of technical issues by means of formulation, process or machine modifications, providing innovative solutions to issues at hand.
•Generate and execute documentation to support design, implementation & qualification activities within a cGMP environment.
•Support FDA pre-approval and post-approval inspections by serving as technical expert for development and processing operations.
•Prepare Development Reports and CMC sections of DMFs or NDAs related to formulation/process development, process scale-up, process control and comparisons of development and commercial processes.
•Present, where appropriate, technical data to internal / external audit groups (including HPRA & FDA) and commercial partners.
•Ensure all company and departmental policies and procedures are adhered to.
•Third level qualification in a Science or Engineering Discipline (to level 7).
•Minimum of 5-8 years’ experience of process development/engineering, formulation and related commercial scale-up/manufacturing preferably in the pharmaceutical industry.
•Strong technical and project management skills.
•Demonstrated track record in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions in the pharmaceutical industry.
•Strong experience in statistical analysis, sample sizing, Anova, DOE, regression analysis an advantage
•Strong knowledge of the mechanical and thermodynamic theory of pharmaceutical processing equipment an advantage
•Adaptable to changing priorities.
To apply please contact Mary Mullin in Collins McNicholas on 09064 78104 or email firstname.lastname@example.org