Manufacturing Engineer II

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Manufacturing Engineer 2 will provide support towards pharmaceutical manufacturing equipment, critical utility systems and facility, for technical GMP requirements toward the successful installation and start-up of a new Bio-therapeutic Manufacturing Area including manufacturing support of sustained operations while in a production state.

Job requirements for equipment will include URS development, FAT execution, installation support, commissioning / validation, SOP development, Preventive Maintenance job plan development, production support, and efficiency improvement initiatives.

This role is accountable for delivering solutions to an approved budget and schedule commitments while meeting required quality and compliance standards, thus will be required to follow an established project plan structure and lead/contribute to delivering on-budget, on-time results, along with the capability to receive FDA and Health Canada Approvals.

This role will require the incumbent to lead investigator for authoring change control documentation, authoring / supporting deviations / manufacturing non-conformances and CAPAs, and authoring risk assessments.

What will you be doing?

• Actively involved in daily operations when required to meet schedules or to resolve problems. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with multiple departments in developing requirements and recommendations for system modifications.
• Technical translation and execution of all validation requirements for new and/or modified manufacturing, and utilities equipment/systems, ensuring equipment and utility systems are available for GMP Manufacturing, in a state of compliance, and reliably performing to their validated function. Active participation of Factory Acceptance Testing (FAT), Commissioning of new equipment, IQ/OQ/PQ, Validation Summary Reports, Part 11 Compliance, etc, as required for Manufacturing, Utilities, and Computerized systems.
• Generate any associated quality documentation requirements such as SOPs, Change Controls, URS, Room Specification, Validation protocols, Job Plan instructions, Non-Conformances, and CAPAs. Will also perform Risk Assessments and/or Gap assessments for equipment, process, method, and/or facility tech transfers.
• Develop and lead one or more projects, ensuring technical alignment with the commercial and marketing strategy and leading the project team to key achievements and targets. Drives the development and operational delivery of the project plan in accordance with Project Management standard methodologies, Smith+Nephew SOPs, guidance documents, and the product profile. Leads Project risks, budget, schedule variance, and organizational change for the project. Reports to executive management as appropriate. Completes capital requests and purchase orders as needed to support projects.

What will you need to be successful?

• Bachelor of Science in Engineering or related field.
• Minimum of 3 years' experience in a Pharmaceutical/Biotech environment or 2 years in a Manufacturing Engineer role.
• Project management experience.
• Knowledge in aseptic manufacturing and fermentation processes.
• Knowledge in clean utilities (Purified Water, Clean Steam, Compressed air, etc.).
• Design documentation, Equipment manual, and P&ID interpretation (in the English language).
• Alignment to Quality Systems and Good Manufacturing Practices with accurate attention to detail.
• Ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant.
• Ability to influence team members, peers, and senior managers in a matrix environment.
• Strong analytical and solving skills.
• Ability to prioritize different projects along with multitasking.
• Effective verbal and written communication skills.
• Software: MS Project or Excel, Word, and PowerPoint.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.