- Reference: 45306
- Job Type: Permanent
- Location: Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
Senior Process Engineer – Permanent – MIDLANDS – Interviews Mid Sept 2017
To Join a US rapidly emerging Biopharmaceutical company who are expanding global operations into Ireland. The new world class manufacturing facility will be based in the Midlands of Ireland and manufacturing products for the global markets. The site will be a fully functional operation covering all aspects from manufacturing through to operational support for regions on site. This is a great opporunity to join at the very early stages of this progressive Bio-Tech Manufacturing facility set up.
As a key member of the Ireland team, the Senior Equipment Engineer will apply strong fundamental engineering expertise in support of design, construction, commissioning and qualification of process equipment for the Clinical and Commercial Manufacturing facilities in Ireland. The successful candidate will have strong knowledge of engineering, fabrication, commissioning, and qualification activities for bespoke equipment used in aseptic manufacturing processes. The demonstrated ability to work with equipment designers and fabricators as well as the ability to handle multiple projects and/or tasks is desirable.
Duties & Responsibilities:
- Develop an expert understanding of the manufacturing equipment used in the unique and proprietary manufacturing process. This will require one (or more) extended assignment(s) working in the companies current manufacturing facility in the United States.
- Participate in the vendor selection process for new equipment for the Ireland facility.
- Oversee the designing, fabrication and delivery of process equipment for Ireland’s new facilities.
- Collaborate with subject matter experts to incorporate improvements to current equipment designs.
- Review vendor designs, drawings and/or specifications
- Participate in periodic visits to vendor location(s) to review progress, resolve issues and/or participate in factory acceptance testing. Travel to vendor locations will be required.
- Prepare periodic project status reports as required by Company management.
- Interface with Company Legal and Procurement teams to develop and administer contracts for procured production equipment.
- Interface with equipment vendors to track progress of process equipment fabrication and delivery.
- Develop Equipment FAT/SAT, Commissioning and Qualification plans.
- Negotiate change orders with equipment suppliers.
- Participate in development of Technology Transfer and Validation Master Plans.
- BS in Engineering or other technical discipline
- Minimum of 8 years of progressively responsible engineering experience.
- Design of equipment for aseptic manufacturing processes
- Design of highly automated manufacturing systems
- Validation of aspect manufacturing equipment
- Experience in cGMP Manufacturing and/or Development at a biotechnology, pharmaceutical, or medical device company is desirable
- Knowledge of Combination product or device is highly desirable
- Demonstrated ability to oversee equipment projects through the entire project lifecycle (design through validation)
- Experience managing and expediting fabrication and delivery of custom-engineered equipment
- Experience interfacing with Project Management, Quality, Regulatory, Legal, Financial and Procurement functions.
- Ability to prepare and deliver project status updates to Company management and Project Stakeholders.
- Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization
- Proactive, forward-thinking and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines
- Familiarity with domestic and international cGMP regulations and industrial guidance documents (e.g., CFRs, ICH, etc.)
- Energetic individual with can-do attitude and demonstrated team player
- Solid Engineering skills
- Working knowledge of cGMP pharmaceutical manufacturing
- Good interpersonal, follow up, and excellent verbal and written communication skills
- Keen attention to details
- Ability to handle multiple project priorities with exceptional organizational and time management skills
- Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment
- Self-motivated and willing to accept responsibilities outside of initial job description
- Strong team player aligned with Corporate Values
Our clients are in Ireland Mid-September and hoping to meet potential candidates.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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