La sarl Orion Lab, société de production pharmaceutique située à Hassi Ameur, Oran recrute dans l'immédiat un Ingeenering Manager.

Le titulaire du poste aura les responsabilités et taches suivantes:

KEY RESPONSIBILITIES

• Manage equipment and utility related projects, including: on-site installation,p, and commissioning activities for new equipment/systems
• Generate user requirements and engineering specifications for new equipment within area of responsibility
• Develops/reviews and approves design documents, drawings, project plans, change controls, SOPs, PMs, cals, work orders, validation protocols and final reports and ensures compliance with cGMPs and current regulatory requirements. Resolves all deviations/discrepancies encountered during project execution
• Responsible for the reliability of the production process (reliability of Validated Systems, Critical Utilities, and Production related systems is critical to the ability of the Lexington Facilities to successfully manufacture parenteral products).
• Built and Improves key metrics (KPIs) around planning and scheduling (unplanned downtime, OEE, etc).
• Ownership of process equipment including continuous improvement
• Assist in the development of a robust operations and maintenance strategy
• Assist in the development of reliable and cost-effective spare parts program.
• Supports Operations including troubleshooting, emergency response
• Coordinate and conduct risk assessments
• .Reviews change requests for impact to equipment or process and supports QA compliance activities such as Product Quality Review.
• Represents Technical Subject Matter Expert (SME) in equipment, facilities, process and utilities.
• Offers input for all functional budgeting, hiring, mentoring, employee evaluations and future direction of the Facilities/Engineering functions
• Drive the manufacturing equipment/technology, automation, and facility strategies forward.
• Lead process and product scale-up throughout the site, including troubleshooting complex engineering problems
• Ensure successful technological transfer of new products developed from R&D to commercial manufacturing and commercial site transfers.
• Manage / update site master plan to ensure alignment with strategy and updates to business and outside landscapes.
• Manage the Engineering Budget by monthly review and cost controls to ensure compliance
• Audit cGMP documentation of work performed.
• Ensure FMEA is followed and that the process output for required spare parts inventories is maintained
• Provide performance management including career development, coaching & mentoring, and adhering to the PPS timelines and milestones for performance reviews and goal setting for all direct reports.
• Reduces downtime in accordance with applicable company and regulatory guidelines

WORK ENVIROMENT

• Ability to work in a high demand office setting and mechanical rooms, spending extended time troubleshooting equipment and or making systems improvements.
• Laboratory/manufacturing setting with exposure to dust, odor, noise, and fumes may be present.
• Position may require extended hours including evenings and weekends,
• Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position

EDUCATION REQUIREMENTS:

• Bachelor’s degree in Mechanical Engineering or closely related scientific field

WORK EXPERIENCE :

• +10 years working within a pharmaceutical manufacturing, medical device environment or food industry
• +7 years of leadership experience, directly supervising a team of engineers, technicians and different contractors

FUNCTIONAL OR TECHNICAL SKILLS:

·         Expertise in Engineering Project Management

·         Working knowledge of pharmaceutical processing equipment — Granulation, compression, coating, encapsulation, Steam Sterilizers, Depyrogenation, Lyophilizers, Water Systems, VHP Generators, Lab Equipment, , HEPA Air Handling unit, Isolators and ETP

• Strong PC skills with standard office application (Word, Excel, PowerPoint) competency.
• Experience with MS Project or similar PM tools.
• Experience with AutoCAD or similar CAD tools.
• Knowledge and understanding of cGMPs including local regulation, FDA and EU regulations.
• Ability to lead and manage in approving function activities, following through to completion; must work with other functional groups’ priorities in order to drive Engineering projects to completion within the committed schedule.
• Must be able to interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies; must also interact with vendors and consultants on a routine basis.

Other Requirement

·         Preferably living in Oran.

·         Fluent in English and French

·         Good communication and presentation skills

·         Available immediately