Sr Engineer II, Manufacturing

Full-time - Mid Level

NC

About the position

This role designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets. Responsible for leading, tracking, and coordinating activities related to the GMP manufacturing process equipment. Provides project engineering as required for new processing equipment installations and modifications to existing equipment. Aids in the development of junior engineers as appropriate. Able to manage small to medium engineering projects with little direction. Work with and provide direction to contractors. Lead multi-function teams to implement change and improve on existing processes locally and globally.

Responsibilities

• Support Manufacturing operations by troubleshooting issues and identifying equipment system improvements.
• Update standards, drawings and specifications as necessary.
• Identify and lead equipment related projects, including technology transfers, capital projects, and modifications.
• Complete project management tracking of deliverables for metrics & reporting.
• Provide input & guidance to Tech Transfer and project / area efforts.
• Provide technical evaluations of validation requirements for core change controls & associated action plans.
• Author sections of Validation-related reports & project plans.
• Approve Trackwise-generated workflows (deviations, global change controls) for equipment / automation-related changes.
• Review automation protocols, & attend related meetings.
• Coordinate Equipment/Cleaning Validation Protocols (development, training, management, tracking).
• Specifically design & develop validation protocols.
• Provide expertise to associated equipment & automation design / modifications.
• Support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.
• Maintain personal training, goal development / completion, compliance workflow tracking, & progress tracking.
• Represent Engineering department on various industry societies and forums (e.g. – ISPE, BioPhorum).
• Ensure effective communication of validation strategy, risks, and overall plans to leadership and teams.
• Represent engineering and validation systems, data packages and submissions in regulatory audits.
• Lead validation lifecycle management of validated equipment including regulatory questions / requests of validated systems.
• Authoring and management of Validation Master Plan and Cleaning Strategy documents.

Requirements

• Bachelor's degree in engineering.
• Practical knowledge and application of GMP and EMA regulations.
• 8 years of direct engineering and validation experience on manufacturing equipment in a pharmaceutical or biotech environment.
• Competency in Process Controls and Distributed Controls Systems, MS Word, MS Excel, MS Power Point and MS Project.
• Excellent oral and written communication skills.
• Ability to work rotating shifts, extended shifts and weekends as needed.

Nice-to-haves

• Experience with either Fill Finish, Isolator (Bausch and Stroebel) and Lyophilizer technologies preferred.

Benefits

• Medical, Dental, Vision, & Life insurances.
• Fitness & Wellness programs including a fitness reimbursement.
• Short- and Long-Term Disability insurance.
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31).
• Up to 12 company paid holidays + 3 paid days off for Personal Significance.
• 80 hours of sick time per calendar year.
• Paid Maternity and Parental Leave benefit.
• 401(k) program participation with company matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Employee Resource Groups participation.