Lead Packaging Process Engineer
Cpl are delighted to work with our Pharmaceutical client partner to source a Packaging Process Engineer for their External Operations team.
In this new and exciting role as Packaging Engineer, you will be a key stakeholder in the External Operations Manufacturing team with a Global brand leader in outsourced Pharmaceutical R&D and Manufacture.
With an interesting portfolio of clients and very exciting career opportunities ahead, this is primarily a remote role offering a tremendous degree of flexibility and the External Op’s division are working in a very close partnership model with several CMO partners across the EU and USA.
The Packaging process expert will be required to support new product introductions, technology transfers, continually monitor and improve packaging operations conducted at Packaging Contract Manufacturing Organizations’ (CMO’s in the USA and EU)
· Responsible for the day to day packaging process operations conducted on behalf of the company at various packaging CMO’s.
· You will be the process owner for the manufacturing processes and ensure the manufacturing process operates effectively and efficiently, to ensure excellence in the supply of product to our patient’s
· You will work with packaging CMO’s to maintain and publish KPIs that are focused on delivering the most efficient packaging process
· Conduct process engineering investigations in conjunction with CMO and cross functional support teams to ensure root cause is identified and sustainable CAPAs are in place. Develop and implement cost justified process and equipment improvements, identify and eliminate repetitious machine failures, troubleshoot equipment and process issues and implement improvements under change control, improve manufacturing efficiency by analysing work flow, space requirements and equipment layout, prepare process reports by collecting, analysing and summarizing information and trends.
· With support across the business, the Packaging Process Engineer will work closely with the CMO team to support ongoing NPI / Technology Transfer projects and production support works as needed, ensure Standard Operating Procedures are continually updated to streamline and optimize the process.
· With support, you will also work with CMO’s to develop and execute validations on new equipment and processes to the manufacturing facility; ensure excellence in the development and deployment of validation elements including URS, FMEA, IQ, OQ, PQ etc.
· Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs, work in conjunction with other departments to ensure production, quality and safety targets are met and drive systems and processes to eliminate customer complaints.
· Ideally you will have M.S. in Process Engineering, Packaging Science or equivalent 2 years’ experience in high volume pharmaceutical and/or healthcare packaging, providing engineering support for new product/process introductions in accordance with EHS and cGMP standards in pharmaceutical or healthcare packaging industry
· You will have a sinifigant degree of Experience working in a validated environment with strong discipline about change control and risk assessment to evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements.
· As the Packaging engineer you will have Proven problem-solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action and timely close out of investigations and associated CAPA’s
· An In-depth knowledge of primary and secondary packaging of pharmaceutical drug products (Tablets/Capsules/Vials/Syringe) with knowledge of global regulatory requirements related to design and control of these processes is essential.
· Strong mechanical capability with hands on experience with equipment, preferably experience in a technical role within a high-volume manufacturing environment
· Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerance’s and associated relationship with materials, product and process design deployed within the packaging design
· Excellent verbal, written communications including technical report and investigation writing aligned with excellent presentations skills and influencing skills
· There will be approximately 20% -25% of international travel associated with this role (obviously in the current Covid-19 client that is not the case but when we are back to a “post Covid normality in 2021” the travel to CMO partner sites as well as some occasional travel to colleagues in the US will come back into the role.)
If you are an established and proven Packaging Lead Engineer from GMP or similar regulated industries and you are interested in an extremely refreshing, new and exciting job opportunity then please send me your CV for review and with feedback on total guaranteed withing 48 hours.