Experienced Engineer - Cleaning Validation

Job Summary

Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bioprocessing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.

Essential Job Duties and Responsibilities

We have a great opportunity for an Experienced Engineer to join our MSAT Cleaning Validation team. The Experienced Engineer will be responsible for the following:

• Conduct MSAT activities in compliance with US and EU regulations, local and global procedures and EHS&S requirements. Primary activities are in the Cleaning Validation area.
• Performing cleaning Cycle Development, Performance Qualifications, Clean Hold Studies, and Re-Qualification executions.
• Develop MSAT documentation (e.g. protocols, procedures, reports) and co-ordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing / the project schedule.
• Co-ordinate MSAT activities with contractors and vendors as required.
• Attend identified training, required to fulfill the role of a Senior MSAT Engineer.
• Participate in multi-functional teams (project, investigations) as required.

Minimum Qualification

• Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field is required.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g MS Office, Excel, SAP.
• At least 3 yrs experience in the pharmaceutical manufacturing industry or equivalent.
• Must be able to work independently with minimum supervision to meet tight deadlines.

Other Requirements

• Experience in biological Cleaning Validation (Minimum 2 years).
• Also, beneficial would be experience in Projects, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Thermal Validation, supporting process improvement projects, Supporting New product Introduction/ process validation.
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
• Ability to lead multi-functional team and to manage complexity and change.
• Proven knowledge and application of industry regulations including those of FDA, EMEA, and other authorities.