Senior Manager, Process Engineering

Objectives/Purpose Of Job

The Senior Manager is a member of the Pharma and Lens Care Solutions Technical Services team, responsible for providing strategic technical leadership and project oversight to the Global Process Engineering Team within the Pharmaceuticals/Consumer and Lens Care business vertical. This position will support following internal plants in B+L network: Tampa, Greenville, Milan, and Jinan, China.

Key Activities/Responsibilities

• Process + Cost Improvement

• Provide process solutions when transferring sterile products from B+L internal or external manufacturing sites
• Develop and validate processes for new and existing products on new equipment
• Evaluate compounding and filling processes for cost effectiveness, considering material options, global sourcing, manufacturability, shipping cost, and stability programs
• May support specific business development activities, including due diligence and strategic partnerships

• Supply Continuity

• Ensure sterile products compliance with necessary regulations (ISO, USP, FDA, EMA, ANVISA, etc.) and applicable testing methods for use in pharmaceutical and medical device applications
• Support Maintenance of Business (MOB) tech. transfers or New Products Introduction (NPI) from R&D at multiple internal and contractor manufacturers’ locations while ensuring uninterrupted product supply
• Provide technical guidance and input to the critical process parameters, qualifications, and improvement of aseptic processes
• Develop, manage and sustain documentation of tech. transfer packages to ensure high level accuracy and consistency including technical and compliance oversight to protocol generation, report closeouts and technical packages
• Provide technical support for the vendor evaluation and selection process

• Governance & Compliance

• Prepare and present Business Gate Reviews to ensure alignment and approval of new project or prioritization in existing portfolio
• Ensure compliance with SOPs, GMPs, design control, EHS standards, and regulatory requirements

• Leadership & Talent Management

• Lead and manage a team of process engineers to ensure successful execution of projects and programs
• Provide coaching, mentorship, and career development opportunities for engineering staff
• Collaborate with HR to attract, retain and grow high-performing talent
• Manage the performance, succession planning, and annual compensation process for their assigned team
• Address performance challenges constructively and proactively
• Create technology roadmaps and develop execution plans
• May support business development activities, including due diligence and strategic partnerships
• Grow department DFSS and Six Sigma capabilities

• Budget Management

• Create and manage department budgets
• Provide budget / forecast expense input for MOB Pharma/Consumer/Lens Care project requirements both externally and internally
• Take on individual project leadership roles as required

Qualifications/Training

• Education:

• Bachelor's or Master’s degree in Chemical Engineering or related Engineering, or physical science degree
• Advanced degree in science, engineering or business preferred

• Experience:

• 10+ years of relevant Process Engineering experience in a regulated pharmaceutical or medical device industry and with minimum 3 yrs management experience (or equivalent) with direct reports highly preferred

• Special Skills:

• Experience in Process Engineering, including tech. transfers and advanced validation methodologies (IQ/OQ/PQ/PV)
• Experience working in aseptic or sterile manufacturing environments is highly preferred
• Experience with new product development and structured phase gate processes
• Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical/lens care environment
• Excellent communication, organization, and presentation skills required
• Computer Literacy with skills in MS Office applications and project management tools
• Demonstrated business acumen
• Demonstrated ability in designing experiments, qualifying and validating materials, components and processes, and resolving technical issues with suppliers and contractor facilities
• Proven expertise in designing, implementing, and monitoring process improvement initiatives
• Ability of identifying opportunities for continuous improvement
• Systems Thinking & Operational Efficiency Experience defining and implementing policies, procedures, and systems to drive organizational effectiveness and sustainable initiatives and compliance with emerging environmental standards
• Performance Under Pressure Highly effective at managing multiple competing priorities and deadlines, while maintaining positive, collaborative relationships
• Leadership & Influence Highly flexible: comfortable as a leader, contributor, or influencer. Skilled in leading through complex organizational dynamics, with the ability to influence, inspire, and achieve results through others
• Motivation & Team Enablement Demonstrates high energy and a results-driven mindset, consistently motivating teams to enable performance at all levels