Engineering Compliance & Contract Lead

Engineering

icon-location-marker Cruiserath - IE
Posted 21 days ago Full_time R1518158

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture (MPCC) biologics manufacturing facility in Ireland, Cruiserath, Dublin 15 - a $1 billion investment. This new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.

BMS Cruiserath Biologics is seeking to recruit a permanent Engineering Compliance & Contract Lead within the Utilities & Facilities Team.  Reporting to the Associate Director of Utilities & Facilities, the Engineering Compliance & Contract Lead will be working as part of the team to deliver facility related services across the site.  The successful candidate will manage the services providers delivering services across the site to ensure the site is complying with all necessary Regulatory & Corporate Requirements.

Key Duties and Responsibilities:

  • Manage GxP facilities related Service Provider contracts (GxP cleaning & pest control) to ensure effective support of operational activities.
  • Oversees Service Providers to ensure their compliance with applicable national and local regulations and laws, company policies and procedures, and current Good Manufacturing Procedures.
  • Fulfils the role as Subject Matter Expert for GMP cleaning and site pest control for agency inspections.
  • Through Service Providers maintains the facility in a GMP state and audit ready at all times. Own physical facility and maintenance & repair programme
  • Own GMP cleaning, compliance & governing SOP's, RA's etc. Support cleaning Investigations as required
  • Own pest control programme management & governing SOP's, RA's etc. Ownership of investigations
  • Own GMP Gowning & Lab Coat Service Delivery
  • Permit issuer for Facility owned works
  • Permit area owner for works in Facilities owned areas 
  • Deliver through SP's other non-GMP services. Bundled Services - MPCC stationary distribution, LN2 dewer movement, FM tickets etc.
  • Optimisation of service provider contracts and the services they deliver
  • Development and manage services contracts and budgets with Service Providers.
  • Overseeing service delivery and maintaining and growing relationships with Service Providers in partnership with BMS stakeholders such as Operations, Maintenance, EHS, Quality, Procurement, global departments.
  • Ensuring all the operating systems are in compliance with all Regulatory and Legal requirements including, EPA licence, Quality (cGDP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures.
  • Participation in regulatory and corporate audits.

 

Qualifications, Knowledge and Skills Required:

  • The successful candidate must possess Bachelors (Level 8) Science/Engineering discipline with at least 6 years’ experience providing technical expertise on an operating site.
  • Strong leadership, performance management and employee development skills.
  • GMP experience and safety knowledge.  
  • Strong project management skills (i.e. budget tracking, schedule development and adherence, project reporting, etc.)
  • Familiarity with manufacturing environments
  • Demonstrated communication, administrative and leadership skills with ability to work well with other departments, and effectively and efficiently lead in a team environment.
  • Proven ability to manage multiple priorities in a fast-paced environment. Ability to understand, implement, and monitor regulatory and safety guidelines applicable to the pharmaceutical industry.

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level:

Passion: We pursue excellence to help patients prevail.

Innovation: We embrace new ideas.

Accountability: We own our outcomes and the outcomes of others.

Speed: We act with urgency and agility.

Why should you apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days,  life assurance, on-site gym and gain-sharing bonus.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.