Regional EM Engineering Lead

External Manufacturing Engineering Lead

The role ensures External Manufacturing delivers products to patients through strong engineering performance at Contract Manufacturing Organization (CMO) sites. Reporting to the External Manufacturing Engineering Lead, the role is integral in delivering new product introduction from R&D (Research and Development), business development deals and existing GSK products through the full range of engineering input; site assessments, capital management, trouble-shooting and multi-site engineering programs.

As the role has a focus on Large Molecule Drug Substance activity, strong knowledge of the engineering aspects of this dose form is necessary. This expertise will also carry over to internal GSK sites when support is required.

Accountability for a portion of the ~150 site External Manufacturing (EM) network, which covers Medicines and Vaccines Large Molecule Drug Substance and Drug Product, Medicine Small Molecule API and secondary, including newer product types such as Antibody Drug Conjugates and Oligonucleotides. As the Engineering Subject Matter Expert (SME) for Large Molecule Drug Substance, the role also supports internal Large Molecule Drug Substance sites.

• The scope of the below responsibilities can cover either a portion or all of EM as well as the internal GSK Large Molecule Drug Substance sites:

  • Engineering performance accountability (equipment uptime, engineering safety and quality compliance) through engagement including site visits/audits and virtual engagement.

• Oversight and accountability for key capital project delivery, enabling new product launch/supply continuity.

• Responsibilities as the Large Molecule Drug Substance Engineering Subject Matter Expert.

• Programs or actions to support delivery of the External Manufacturing strategic objectives (safety improvements, waste elimination, product cycle time reduction etc.)

• Delivery of improvement programs e.g. Extractables & Leachables, PFAS, obsolescence management.

• Engineering input into the development of recommendations from the GSC (Global Supply Chain) Strategy team.

• Possible ownership of the External Manufacturing capital plan.

• Engineering capability building of the External Manufacturing team and the external sites.

• Collaborative working with Smart Manufacturing and the Tech team to integrate Engineering activities.

Basic Qualification

• A minimum of a HND (Higher National Diploma) or an associate degree is required, along with relevant experience in engineering disciplines such as Chemical, Mechanical, Electrical, or Automation.

• Minimum 10 years' experience in relevant roles, with a focus on Large Molecule Drug Substance.

• Project or program delivery of large capital projects.

• Experience with GSC Engineering Policies, Standards and the Project Management Framework.

Preferred Qualification

• Bachelor's or Master's degree in engineering.

• Experience in Drug Product Engineering.

• Engineering experience in conjugation projects/operations.

• Engineering experience in small molecule – primary and secondary, including API (Active Pharmaceutical Ingredient) /high toxicity API manufacture.

• Capital project delivery experience at a Large Molecule Drug Substance/Drug Product site.

• Experience of the GSC EHS (Environment, Health, and Safety) Standards.

• Experience with broader site/central engineering roles covering utilities, compliance and facilities.

• Experience working with external manufacturing sites.

• Relationship management, with either internal or external individuals/ teams/ companies, potentially across the world.

This role offers a hybrid working model, with a mix of on-site and remote work. This role also requires approximately 25% travel, both domestic and international, depending on business requirements.

Other locations than those defined in the job advert will be considered under exceptional circumstances.

How to apply

We want to hear from you. Please apply with your CV and a short note describing how your experience matches the role. If you have questions, include them in your application and we will follow up. Join us and help shape operational excellence that supports our mission to get ahead of disease together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.