Engineering Manager - Pharmaceutical

SUMMARY:
Isando, Kempton Park

POSITION INFO:

Position Summary and Objective:

• Manage and maintain overall engineering activities including design, development, production, and testing.
• To optimize the running of the plant, through efficient resource planning and scheduling of maintenance activities according to the Planned Maintenance System.
• To lead a robust project management process and delivery timelines to keep projects on schedule and budget.
• Ensure that all engineering activities adhere to OSH Act requirements.

Primary Responsibilities:

Operational Requirements

• Provide direction and support to the production team in achieving optimal outputs on manufacturing and Packaging equipment.
• Ensure that all essential services such as Boilers, Compressors, Chillers, HVAC units etc are always functional and in the event of a breakdown that the repairs are conducted timeously.
• Ensure that all PPM''''''''S are concluded, documented, and completed on time and trended as per operational requirements.
• Ensure that control systems are functioning correctly and that the systems are monitored according to SOP''''''''s.
• Ensure that ad-hoc maintenance requirements are managed efficiently.
• Responsible for statutory requirements of services and utilities in line with the OSH Act and local municipality requirements.
• Ensure that all engineering work conducted by artisans are executed according to GMP standards, SOPs and equipment protocols.
• Compile and maintain all relevant engineering SOPs, work instructions and equipment logbooks.
• Ensure that QA audit requirements are met, CAPAs compiled and closed appropriately.
• Ensure that engineering staff comply with the safety procedures at all times.

Assist with security related projects and the daily function of Security related equipment and personnel.

Equipment Maintenance

• Ensure that equipment is maintained as per OEM requirements at a minimum.
• Ensure that any alterations and modifications to equipment are done in accordance with the GMP and operational requirements.
• Supervise all third-party contractor work.
• When necessary, initiate user requirement specifications, change controls and risk assessment documents to support changes and/or additions.
• Review Engineering related service contracts annually.
• Ensure that the Planned Preventative Maintenance program is reviewed periodically to identify gaps and improve efficiency.
• Ensure that the maintenance service providers deliver a satisfactory and timeous service.
• Ensure that equipment downtime is kept at a minimum.
• Review and analyse machinery downtimes reports in accordance with Standard Operating Procedures.

Project Management

• Ensure that projects are meticulously planned and executed as per agreed timelines and within budget.
• Project planning and implementation must be executed according to agreed user requirements, SOP’s and operational requirements.

• Manage and coordinate projects between all departments in line with the set deadlines.

People Management

• Ensure efficient resource planning to support site engineering requirements.
• Promote a working environment to ensure high levels of morale, performance, motivation, mutual respect, and team spirit.
• Ensure that tasks are delegated efficiently within the engineering team.
• Ensure ongoing staff development to enhance skills and competency.
• Ensure that engineering personnel are available on standby after hours when required.
• Train staff in accordance with annual appraisals and quarterly reviews on the new Standard Operating Procedures as and when required.

Site/ Infrastructure and Process Management

• Review and approve utility system modifications, change requests, and SOP’s.
• Develop and champion continuous improvement programs that increase the performance and reliability of utility equipment and systems.
• Support Validation, Warehouse, QC, QA, and other departments on all Utilities and Projects/Issues regarding specification, scope definition, budget preparation, detailed engineering design, purchasing, inspection, Validation,
• Installation and Commissioning of all new machinery and building works.
• • Review, prepare and submit site energy efficiency reports as required.
  • Develop and maintain relationships with external service providers and municipalities to ensure that their services are at the required level.
  • Ensure that all standby mechanisms for delivery of water, Power and other such needs are in place and operational.

  • Proxy Responsibilities

    • Assist with Health and Safety requirements in line with the OSH Act in the absence of the EHS Manager, including but not limited to:
    • Health and safety schedule, reporting, assist EHS Manager with safety Rep, fire fighters and first aider training as well as assist EHS Manager to ensure duties as required and monthly reporting are done.
    • Assist EHS Manager with Engineering related tasks such as signage, Supplier Safety files and other related tasks.
    Assist the EHS Manager to achieve agreed goals relating to Engineering functions required by EHS.