The Role
- C&Q Program Lead
- Sligo
- Onsite role – no remote working offered
- Permanent or Contractor Opportunity
Role Brief
As the program lead, you will be based out of a Sligo site of an SL Controls client. You will lead a team to deliver a specific project. the project is focused on both a conjugation and an aseptic fill line program.
Key Tasks:
- Planning and coordination of C&Q activities in line with a risk-based approach (RBV).
- Support concept design, detailed design development and planning.
- Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs.
- Standardize the C&Q approach across the network.
- Assessment of third-party C&Q support and / or the assessment of individual candidates for specific project roles.
- Manage C&Q teams / team coordinators to deliver key GE lead projects across the network.
- Track project progress in line with agreed schedules week on week.
- Support issue resolution through close working ties with the cross functional teams.
- Support protocol execution and reporting activities when required.
- Provide guidance and advisement to C&Q personnel.
- International Travel to support C&Q execution and management of FAT’s as well as on site execution activities.
- Assist with feasibility analysis such as cost / timeline estimations for new project proposals.
- Work closely with key GE members and central services personnel to upskill. Become proficient with global engineering standards with particular focus on qualification and validation as well engineering standards specific to facilities, Utilities and Equipment.
Skills Brief
- Degree in a Science, Engineering, or computer science discipline
- Minimum 5 years’ experience in the pharmaceutical industry in a C&Q / Validation role.
- Extensive Knowledge of Pharmaceutical Regulatory Requirements.
- Experience in working with Pharmaceutical Equipment Manufacturers.
- Multi-disciplinary experience: Facilities, Utilities, Equipment, Cleaning, Sterilization, Inspection, Computer System Validation and Process validation.
- Must have previous experience in a project management role, managing of a team of C&Q engineers
- Experience in Risk based Verification (RBV).
- Detailed Understanding of risk-based verification requirements for facility, utility, and equipment (FUE) qualification.
- Experience with conjugation and aseptic fill finish manufacturing practices.
- High degree of knowledge of all relevant EU/FDA regulations.
- Strong understanding of current data integrity and data management requirements.
- Demonstrated ability to coordinate activities in an efficient and effective manner.
- Experience with paperless validation solutions such as Kneat would be beneficial.
- Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
Person Brief
Candidates must have a B.Sc. degree in Engineering or equivalent, with emphasis in software development, electrical, electronic or automation discipline, with a minimum of 10 years’ automation industry experience, preferably in a pharmaceutical, biotechnology, blue chip or relevant GMP manufacturing environment. The ideal candidate will have excellent communication skills and strong problem skills.
Significant specific C&Q experience is required in the Pharmaceutical or Medical Devices sectors. Only candidates with this experience will be considered.
You should be based in Sligo or the North West or be willing to relocate to this location in a short time frame and you must be able to commit to being onsite full time, 5 days a week.
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. SL Controls offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief
SL Controls 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 the past 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.
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