Project Group Lead to deliver the Capital Investment Program for Pharmaceutical Processes, Packaging and Facilities within the FDA and HPRA approved Helsinn Birex facility.
Engineering Project Manager
Reporting to the Engineering Manager, the successful candidate will be primarily responsible for leading a project group to deliver the Capital Investment Program for Pharmaceutical Processes, Packaging and Facilities within the FDA and HPRA approved Helsinn Birex facility. This role will require the leading of diverse and multi-disciplinary site project teams to achieve challenging project goals to the defined EHS standards, cost, schedule and quality requirements of Helsinn.
Current significant site projects include a building extension, development of a high containment manufacturing suite, serialisation of packaging lines and implementation of a barcode system in the site warehouse, along with specific equipment and energy related projects.
The role of the Manager, Projects will primarily involve but is not limited to the following duties and responsibilities;
- Project Management of all Plant Capex projects
- Compiling, Costing and Control of Annual Capex budget
- Management and oversight of site based Project Engineers and Contract Engineers and development of same to ensure a well motivated team
- Participate in strategic planning of future site investments
- Reporting on status of Capex program
- Ensuring that all EHS needs are included from the start of every project and are integral to the working way of the Projects Group
- Technical Lead on relevant Projects
- Leading the Design, Procurement and completion to FAT stage on equipment projects in order to hand over to QA Validation under the site change control system.
- Ensure Projects are handed over in a controlled manner with manuals, training, maintenance systems and site master drawings updated
- Collaborate significantly with internal/external functions and suppliers to finalize process and equipment design.
- Working closely with the Maintenance, Facilities, Automation Control and EHS functions to ensure the goals of the Engineering Dept. and the company are met
The successful candidate must possess the following qualifications, skills, experiences and personal attributes.
- A honours degree in Engineering
- At least 7 years’ experience as a Project Lead within a regulated Pharmaceutical manufacturing environment.
- Excellent time management skills with ability to prioritise and work to strict deadlines.
- Excellent interpersonal, presentation and communications skills coupled with the ability to effectively lead cross-functional teams.
- A proven track record in managing projects in an oral solid dose manufacturing and packaging environment with experience in automated systems to support the manufacturing function.
- Although not essential, it would be highly desirable and advantageous for the candidate to possess previous experience in working and managing projects within a High Containment Manufacturing and Packaging Environment
Helsinn is an Equal Opportunity Employer and Welcomes applicants who meet the above criteria. Applications must be submitted by 30 April 2017. No recruitment agency assistance is required for this vacancy.
The Helsinn Group has a commercial presence in over 90 countries and has proven expertise in areas such as Oncology Supportive Care, Gastrointestinal, and Pain and Inflammation medicines.
This job is based at the Group's finished pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals Ltd (FDA and HPRA approved) which has operated at Damastown Industrial Estate, Mulhuddart, since 1997. HBP develops, manufactures and packages finished dose forms in tablet, granulate, capsule and gel formats. In addition, the company carries out final packaging of special dosage forms such as sterile forms and softgel which are produced by its worldwide network of CMOs. In 2009 HBP opened a pilot scale R&D facility and submitted its first NDA to the FDA in Q4 2013. “Akynzeo” was subsequently approved and commercially launched in October 2014.
Please visit WWW.HELSINN.COM for an in-depth overview of the Group's activities.