Process Engineering- Process Validation Support

Job Summary

Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bio-Processing 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

• Conduct MSAT activities in compliance with US and EU regulations, local and global procedures and EHS&S requirements.
• Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges, In-Line Conditioning Verification Studies, Chemical Hold Studies) area.
• Leading and/or providing technical guidance for process improvement projects and investigations.
• 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 an experienced 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 Process Validation (Minimum 2 years).
• Attention to detail, excellent communication skills, both written and verbal.
• 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.
• Adaptable and flexible with great problem-solving skills.
• 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.