· Required to work closely with the Digital MMD
teams responsible for the full Automation and IT scope and with vendors /
partners with responsibility for commissioning and qualification of DeltaV DCS.
· SME for commissioning and qualification of
DeltaV system
· Responsible for DeltaV commissioning and
qualification activities, including loop testing, onsite commissioning and site
testing through to OQ complete
· Manage Automation change requests that are a
product of CQV activities
· Manage stakeholders to the DeltaV commissioning
and qualification process
· Partner with Computer System Validation (CSV)
and Digital Data Quality (DDQ) teams to ensure compliance with applicable
standards and policies.
· Partner with internal Digital departments
ensuring standard and secure implementation in line with MSD Standards
· DeltaV commissioning plans and execution
records.
· Loop test documentation and completion reports.
· Site testing and commissioning records.
· Operational Qualification (OQ) execution
evidence and reports.
· Automation change request assessments and
implementation records.
· Validation and qualification documentation
supporting CSV deliverables.
· Risk assessments and issue resolution
documentation.
· Stakeholder and project status reports.
· CQV completion and handover documentation.
· Compliance and audit support records.
RequirementsRequired Qualifications and Competencies
· BS
in Engineering, Computer Science, or other technical degree.
· Training
completed in DeltaV standard.
· 5
or more years of experience required in DeltaV application.
· 3
or more years of experience required in site-based Commissioning role in GMP
environment.
· Proven
record of proficiencies associated with commissioning and qualification of
complex systems on capital projects.
· Understanding
of cGMP's, SDLC methodologies and principles.
· Excellent
facilitation, problem solving, and decision-making skills.
· Proven
ability to work in cross functional teams.
· Usual place of work will be MSD Ballydine,
Ireland. This is a site-based role. The successful candidate may sometimes be
required to attend meetings at Vendor premises or other MSD sites as required.
Desired:
· Spray drying experience would be advantageous.
Skills Required
- Bachelor’s degree in Engineering, Computer Science, or another technical discipline
- Completed training in DeltaV standard
- At least 5 years of experience with DeltaV applications
- At least 3 years of site-based commissioning experience in a GMP environment
- Proven experience commissioning and qualifying complex systems on capital projects
- Understanding of cGMP requirements
- Understanding of SDLC methodologies and principles
- Excellent facilitation, problem-solving, and decision-making skills
- Ability to work effectively in cross-functional teams
- Ability to work onsite at MSD Ballydine, Ireland, with occasional attendance at vendor premises or other MSD sites
- Spray drying experience
What We Do
Horizon Controls Group: A global leader in automation consulting, enabling both clients and employees to live on the forefront of evolving technology. Horizon Controls Group is a modern, global technology company, specializing in automation consulting, engineering, and training. Founded on the belief that our people are the difference, we have grown entirely from customer references and successive projects. Our people and their established reputation are our most valued assets. This belief has created a great place to work, enabling us to attract the very best and to give our customers confidence in our superior solutions. Our business is comprised of excellence at every level. We employ a pro-active and comprehensive approach to projects -- asking the right questions, analyzing client needs, and engineering a skilled solution. We are committed to understanding the entire spectrum of your automation challenges and to developing uniquely tailored innovative solutions. Our decision to be vendor-independent enables us to offer tailored solutions and represent your needs free of any conflict of interest. We are aligned exclusively with our customers' goals and system requirements, enabling us to provide maximum value. Ultimately, the ability to harvest maximum value from new systems is dependent on the quality and training of your people. Just as we expect and ensure absolute expertise in our people, we work with you to ensure your team is trained to the specific needs of your organization and remain at the forefront of industry trends. We are a global company operating in the United States from our headquarters in Blue Bell, PA and offices in Indiana, Massachusetts, North Carolina, and California and from Cork in Ireland. This is Horizon Controls Group’s official company LinkedIn page.
