The Role:
- Project Manager - MES
- Hybrid. The role will require onsite presence for set activities and as required. Remote working is possible for other activities but you therefore must be based in Ireland and able to commute onsite as required
- Cavan
- Contract or Permanent Opportunity
Role Brief:
The successful candidate will be responsible for the delivery of new and updated integration functionalities for the Manufacturing Execution Systems for use in production. Responsibility also includes oversight on alignment of Manufacturing Information Systems with Global Operating Specifications.
Core Responsibilities:
- Support the development of test plans with POMS.
- Implementing, testing and deploying the changes as per requirement.
- Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
- Design, create, write and/or make all required changes to ensure equipment and product procedures are aligned to MES processes and vice versa.
- Provide support to other MES system users as required to ensure business continuity.
- Documentation of all activities in line with cGMP requirements.
- Change management: Raising change requests based on the MES Application modification / upgrade requirements from the Business.
- Work as part of a team in designing and developing electronic batch records / workflows within the MES solution.
- Support, troubleshoot and resolve issues within the system.
- Identify and drive continuous improvement opportunities within the MES.
Skills Brief:
- Significant experience with POMSnet is essential and only candidates with this experience will be considered.
- Some experience with the Aquilla version of POMSnet would be advantageous
- Authoring and/or implementation experience with the POMSnet MES software package.
- Experience in C# coding and SQL database knowledge.
- MES experience with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries.
- A minimum of 3 years experience with MES technology in Life Sciences, Pharma or Biotech manufacturing environments.
- Strong project management experience in Life Sciences, Pharma or Biotech manufacturing environments is essential and ideally you will have a recognised Project Management qualification.
Person Brief:
Candidates must have a level 8-degree qualification with minimum of five years’ relevant industry experience in pharmaceutical or biotechnology manufacturing environments. The ideal candidate will have excellent collaboration and communication skills, with the ability to work in a fast paced, dynamic environment. In addition to this, strong attention to detail, including the ability to proofread documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently is required.
You should have a mix of strong and relevant technical skills and proven client and project management skills. The candidate should have experience with POMS system and strong C# coding and SQL Database knowledge. PTL, XML and Power Automate knowledge is desirable.
Ideally you will have 3-5 Years experience in project managing OT projects in a GMP environment.
A PMP / Prince / PgmP Certification is highly advantageous.
The candidate should be based in or near to Cavan in Ireland and able to travel onsite as required. While remote working will be possible for some tasks and functions the role is not possible to undertake fully remote and you will be required to be onsite on a regular basis as per project requirements.
Opportunity Brief:
This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. NNIT Ireland offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief:
NNIT Ireland are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.
Over more than 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.