Senior Manager, Process Engineering

Bausch+Lomb Companies Inc.•Tampa, FL

2d•Onsite

About The Position

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. The Senior Manager leads a team of Process Engineers who provide process engineering solutions covering Maintenance of Business projects and coordination of new R&D products launch with manufacturing and commercial operations both internally and externally. Included are activities related to supply continuity, sustainability, cost improvements, innovative designs and material selections, competitive analysis and strategic tech. transfer input. The Senior Manager may support strategic initiatives or special projects across the broader organization.

Requirements

Bachelor's or Master’s degree in Chemical Engineering or related Engineering, or physical science degree.
10+ years of relevant Process Engineering experience in a regulated pharmaceutical or medical device industry.
Minimum 3 yrs management experience (or equivalent) with direct reports highly preferred.
Experience in Process Engineering, including tech. transfers and advanced validation methodologies (IQ/OQ/PQ/PV).
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.
Experience defining and implementing policies, procedures, and systems to drive organizational effectiveness and sustainable initiatives and compliance with emerging environmental standards.
Highly effective at managing multiple competing priorities and deadlines, while maintaining positive, collaborative relationships.
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.
Demonstrates high energy and a results-driven mindset, consistently motivating teams to enable performance at all levels.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

Advanced degree in science, engineering or business preferred.
Experience working in aseptic or sterile manufacturing environments is highly preferred.

Responsibilities

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, evaluating 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.
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.
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.
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.
Grow department DFSS and Six Sigma capabilities.
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.
Other duties assigned.