Lead Manufacturing Engineer
2 weeks ago
**Lead Manufacturing Engineering**
08.15 - 16.30
Travel: Yes, 5 % of the Time
+ Car Allowance
+ Bonus
**Description - Lead Manufacturing Engineer**
My client is currently looking to fill the position of Manufacturing Engineering Lead within the Commercialization and Validation department to lead an experienced and committed team.
The position will continue to engage and collaborate with stakeholders from program brief to delivery to ensure robust and effective technical commercialization plans, risk analysis, remediation plans, and technical gate alignment.
**Key Responsibilities include - Lead Manufacturing Engineer**
UK Site Operations - NPI & Technical Readiness
Collaborate with other technical development functions through RFT, technical commercialization of new products and technologies ensuring world class quality, robust and repeatable process capability, regulatory compliance (validation/documentation), optimalmargin, at exceptional speed.
Support managers in development and execution of robust, site based commercialization plans for new products and technologies
Develop/revise and execute validation procedures and protocols as related to equipment, utilities, and processes to ensure that products are manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices.To include Operation Qualifications (PPQ) protocols for equipment used in the manufacture of OTC drug product, and Process Performance Qualification protocols for revised and new products or processes
Identify, document and investigate protocol deviations in conjunction with cross functional teams, as required to resolve and close out deviations.
Lead execution gates 5 and 6 pFMEA / risk assessment and remediation plan development and execution for key new product and technology initiatives, collaborating with cross functional technical teams to ensure risk profile is clearly communicated and remediationplans with clear accountabilities are developed and executed
UK Site - Representation and Collaboration with Managers & team:
As needed, represent manager and site based technical commercialization team in technical gate reviews ensuring technical issues are identified and resolved to enable gate progression, delivering expected and aligned commercialization outcomes
In partnership with manager and team, engage / lead commercialization team and stakeholders in site enabled value engineering, champion opportunities to optimize quality, leverage and evolve automation, and collaborate to optimize design, process, cost andperformance of new product and technology elements
In partnership with manager and team, represent site commercialization team in manufacturing location designation (capability and capacity) and program complexity process for new product launches in support of category strategy and RFT commercialization
**Additional Responsibilities**:
Engage / lead new equipment performance specification development to enable and ensure RFT commercialization and long term performance expectations are met
Lead site in feasibility / feasibility cost assessments for new products within their segment of the product portfolio
Participate in technical commercialization process improvement activity across categories and platforms in support of NPL continuous improvement
Drive new product and technology commercialization performance within their segment of the product portfolio versus agreed process KPIs; manage team performance and measure team's ROI
Reasonability and management of Transit Testing & Tertiary package development
**Qualifications**
Relevant industry experience (eg. Pharma, Cosmetics, FMCG).
Demonstrated experience in Pharma / FDA validation
Solid experience as Manufacturing Process Engineer in FMCG manufacturing plant
Excellent NPI experience - leading and delivering new product introductions
Strong presentation skills
Continuously looking to implement Lean manufacturing in all aspects
Exceptional leadership and influence skills
Great collaborator with team members, wider stakeholders and senior management
Experience working to KPIs - RFT, COGs/Margin optimization, Speed to Realization
Preferred Degree: Mechanical / Package / Chemical Eng.
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