Chemical Engineer

A Chemical Engineer is required by CareerWise Recruitment for our Irish based pharmaceutical client. They have a requirement for the candidate to be based in Spain near Barcelona to manage a CMO in Spain. You can work remotely but living in Spain and they are a requirement to go onsite when needed !!!

THE ROLE:

• Work with external partners to achieve business goals and to establish a common culture that benefits our company, external partners, and patients.
• Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers.
• Responsible for technical transfer activities, as applicable, through review of GMP documentation (eg: Master Batch Records, change control, protocols, reports, qualifications, etc.)
• Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
• Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
• Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners
• Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory

• Responsible for participation in creating, sharing, and adopting best practices and business process strategies

JOB REQUIREMENTS

• Bachelor’s degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Science or other related science or engineering field.

• Experience in API chemical manufacturing in an API manufacturing facility.

• Knowledge of GMPs in API manufacturing. A Minimum of 5- 7 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations or Technical Operations

• Experience in Quality Risk Assessments, deviation management and change control.

• Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation
• Experience in Tech Transfers

• Ability to work independently as well as excellent organizational skills.

• Excellent command of English (both written and oral)
• Travel will be a requirement of this position (Person in Plant support during Technical Transfers at External Partners)

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.