Plant Engineering Manager

6 months ago

Brisbane, Australia Thermo Fisher Scientific Full time

**Position Summary**:
Works in a multidisciplinary team for tracking equipment life cycle process on site to ensure that all critical process equipment/systems remain continuously ready for safe, effective, efficient, and compliant operations

Working with the CAPEX engineering, equipment validation, IT and data integrity groups, establish and streamline practices around equipment and/or facility specification, selection, design, procurement and implementation.

Supports CAPEX and facility start-up, commissioning and qualification through to end of life cycle management. Ensures replacements are undertaken to required cGMP and regulatory guidelines and adheres to optimized globally harmonized processes.

Provides expert technical SME knowledge across multi-functional teams comprising Operations, QC, QA and Engineering (including IT and equipment validation) to ensure capital implementation projects are completed within agreed timelines.

Provide equipment and process SME guidance to the proposal team for Brisbane site specific facility fit for early and last stage proposal discussions.

**Key Responsibilities**:
Support equipment implementation and lead global PMO projects endorsed by the SLT

Assist the equipment life cycle from procurement supporting the CAPEX manager to the operational handover and then from end of life planning to decommissioning in both operations and quality control

Support the Snr Manager, engineering and global teams to develop a long term equipment management strategy for the site.

Establish & maintain equipment compliance posture (Safety, Health, cGMP, Bio-Safety, Waste etc.).

Provide SME support to the maintenance planning and execution teams with the mid-term goal to reduce annual maintenance costs on site using a risk based approach.

Work with the MSAT, Engineering and Program Management, departments to support the facility fit and efficiency analysis of new production processes and support client proposals.

Implement practical process improvements (PPI) across the entire equipment and facility lifecycle process to improve efficiency of site processes and implementing best in class global processes.

Responsible for coordinating all quality documentation related to capital engineering implementation projects.

Support operational consultation for annual maintenance planning.

**Frequent Contacts**:
Internal

SLT

Operations

Engineering, IT, CAPEX and Equipment validation

QA,

QC,

MSAT and Process Validation

PM

Finance.

External

Global PMO team

Global Operations and Engineering teams

Customers (as required)

Contractors

**Qualifications & Experience**

Tertiary Degree in Science or Engineering
- 7 to 10 Years in Biologics Manufacturing, preferably in contract manufacturing

Equipment SME in at least 1 technical area within manufacturing or Quality control

Familiar with equipment reliability practices and methodologies (preferred)

Experienced with capital equipment user requirement specification setting, design, start-up commissioning and qualification in a cGMP setting

Familiar with facility fit and operational troubleshooting in either manufacturing or QC setting.

**Behaviors and Competencies**:
Excellent leadership and coaching & mentoring skills

Responsible, reliable, motivated and proactive individual

Strong organisational and planning skills

Excellent social skills, with excellent oral and written communication

Assertive, Principled, yet Flexible

Able to handle ambiguity

Demonstrates agile project management abilities to drive project completion

Leads through the 4”I” values, Intensity, Innovation, Integrity and Involvement

Strong Quality mindset

**Other Job Requirements**:
Adhere to all EH&S policies and procedures and ensures a safe and healthy workplace environment

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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