GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
Job Responsibilities of a Project Engineer:
1. Coordinate site project team to deliver Biological projects.
2. Develop realistic cross functional implementation plans with input from above site and site functions (R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, Supply Chain, Finance, HR).
3. Utilize the relevant PMO tools for project planning, monitoring and reporting.
4. Set project milestone and report progress accordingly. Consider alternative approaches and take corrective actions as needed to ensure project milestones are achieved.
5. Provide program management support for and guide the efforts of third-party organisations (vendors, suppliers, contractors, etc.) to enable achievement of shared milestones.
6. Lead project teams to ensure efficient communication between resources.
7. Engage with all stakeholders to ensure full alignment on priorities and proactively manage and report project risks.
8. Work with cross functional teams to develop required change plans and raise/track change plans in the appropriate systems.
9. Accountable for managing the project timeline and reporting any potential delay/risk on the critical path.
10. Identify and implement opportunities that will improve the organization’s ability to implement and manufacture quality products in a cost effective, compliant, and timely manner.
11. Other duties as assigned, such as facilitating and coordinating communication and actions between site resources and global engineering team in relation to delivery of equipment and the facilities required to support the NPI Program.
Supervision Received:
* Operates in own environment which is largely self-managed but with supervision through the Site Leadership team and Business Excellence Manager.
* Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.
Supervision Provided:
* Have contacts with all levels of management at site and above site (Global functions) as per project requirements: R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, Supply Chain, Finance, HR.
Education:
Essential Requirements:
* Degree in Engineering, Science business, Project management or related discipline.
* PMI certification is desirable.
Desired Requirements:
* Program Management experience.
* Ops experience in Sterile Manufacturing.
* Understanding of Engineering/Equipment/Validation processes used in a sterile environment.
* Previous experience in setting up new Bio processes / equipment / plants and/or NPI.
* Experience with One Vault/ Soltracks system is an advantage.
Technical/Business Knowledge - Job Skills/Experience Required:
* 5 years of diversified Pharma / Bio business experience: operations support, quality, supply chain, validations, capital and expense management, commercial product launches.
Cognitive Skills:
* Requires proven problem-solving skills and the ability to develop strategies for changing business environments.
* Creativity, innovative thinking and decisiveness are necessary to resolve issues and drive the business forward.
* Strong communication skills both verbal and written are required.
* Ability to anticipate challenges and opportunities for the business.
* Strong strategy development and planning skills coupled with necessary knowledge of pharmaceutical manufacturing activities.
* Prioritize their own work in line with business demands.
* Demonstrate and maintain a culture of high integrity and strong business units.
Ownership/Accountability:
* Every employee has a personal responsibility to commit to the Company’s Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the Operational Pillars and Ways of Work.
* Establish timetables, set goals/priorities, develop performance measurements and assign/prioritize resources.
* Measure progress and results accurately and completely.
* Generate ideas for improvement which are consistent with the organization’s mission and strategy.
* Achieve timelines and capital/expense commitments.
Influence/Leadership:
* Will be required to support Cross functional teams and cost improvement projects.
* Build strong collaborative relationships across all departments in the Company and networks within peer groups at Division and Corporate level.
* Seeks and develops new opportunities to sustain the future of the site.
Decision Making/Impact:
* Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
* Play a critical role in making site related decisions.
* Expected to handle all day-to-day queries if major problems can escalate.
* Responsible for presentation of Program data to stakeholders.
Environmental Health & Safety:
* Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
* Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
* Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
* Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
* Attend all required EHS training and medical surveillance programs.
Benefits:
* Highly competitive salaries / hourly rates.
* Career development.
* Mentorship programs.
* Hands-on training.
* Good working culture.
* On-site parking.
Work Authorisation:
* Ireland required.
Job Type: Full-time
Schedule:
* Day shift.
Application question(s):
* Do you have experience in operations support/quality/supply chain/validations in the Pharma industry?
* Do you have experience in setting up new Bio processes / equipment / plants and/or NPI?
Experience:
* Pharma / Bio business experience: 5 years (required).
Work Location: In person.
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