Sr. Engineer, C&Q

Sr. Engineer, C&Q

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Sr Manager Engineering and Automation

Location:

North America, United States, Pennsylvania, Lititz

Work Location:

Fully Onsite

What you will do

The Engineering Commissioning and Qualification (C&Q) Senior Engineer supports and completes site projects requiring C&Q. This role provides technical guidance on C&Q standards, procedures, risk assessments, regulatory requirements, practices, and execution. The Senior Engineer also contributes C&Q requirements to the Product Life Cycle process and collaborates across Engineering—including the Solids and Packaging Technology Platforms—as well as with Quality and Manufacturing teams to strengthen C&Q practices, procedures, and performance measures. As needed, the role supports or leads the implementation of site, regional, and global project and automation strategies that affect C&Q processes. The Senior Engineer supports the site Validation Master Plan (VMP) by developing implementation plans and schedules, authoring or reviewing sub-volumes and supplements, and maintaining C&Q performance metrics. The role also presents C&Q execution strategies, deviations, outcomes, and metrics to applicable site or regional governance bodies and participates in other meetings as needed.

Key Responsibilities

Under limited supervision and in accordance with all applicable federal, state, and local laws and regulations, as well as company policies, procedures, and guidelines, this position:

• Ensures quality and compliance in all actions by:
  • Completing GMP training according to the schedule designated for the role.
  • Strictly adhering to all procedures applicable to the role.
  • Demonstrating the highest level of integrity in all tasks performed.
  • Promptly identifying and reporting workplace deviations and seeking appropriate corrective action.
  • Supporting employee involvement and a commitment to doing the job right the first time.
• Ensures all training in assigned curricula is completed before execution.
• Conducts all internal and external negotiations and activities in accordance with current business conduct principles and ensures these principles are upheld.
• Complies with requirements established by the Environmental Health and Safety (EHS) Program and ISO 14001, including:
• Completes required EHS training and follows applicable policies and procedures.
• Maintains a safe work area and environment by following and promoting rules and procedures related to:
  • Use of personal protective equipment.
  • Fire protection.
  • Reporting spills, including hazardous waste, incidents, and near misses.
  • Compliance with environmental permits and action plans, as applicable to supervisors and managers.
  • Applicable EHS programs, including forklift operations, ergonomics, Lockout/Tagout, and Process Safety Management.
• Encourages and supports peer and employee involvement in EHS considerations for changes affecting safety or the environment, as applicable to exempt employees, supervisors, and managers.
• Generates metrics and verifies employee participation in EHS initiatives and requirements, as applicable to supervisors.
• Promotes employee participation in the site Environmental Management System (ISO 14001), Process Safety Management, and other EHS initiatives, as applicable to management.
• Participates in the site’s waste-reduction and recycling programs.
• Participates in energy-reduction and other environmental protection initiatives.
• Maintains safe behavior in the work area.
• Actively contributes to achieving the organization’s EHS goals and objectives.
• Monitors EHS performance within the work area, as applicable to supervisors and managers.
• Adheres to the EHS business plan for the work area.
• Reports unsafe working conditions or risks and initiates corrective action plans as appropriate.
• Immediately notifies the supervisor of any workplace incident or accident, including an injury or occupational illness. The supervisor or manager must submit an Incident Report within 24 hours of the event.
• Actively participates in the work area’s Ergonomic Exercise Program.
• Provides necessary resources and ensures timely completion of safety-related matters, as applicable to supervisors and managers.
• Maintains in-depth knowledge of current validation practices across the industry.
• Ensures established procedures are followed during all C&Q activities.
• Participates in and, as applicable, leads cross-functional teams to support and complete projects and establish consistent, harmonized validation processes and procedures across company manufacturing sites.
• As applicable, takes a leadership role in company forums focused on validation standards and guidelines.
• Authors and approves standard operating procedures and validation documents as the technical subject-matter expert.
• Ensures site C&Q activities are documented consistently and promptly in the Validation Master Plan and provides metrics on performance against documented plans.
• Informs senior management of the validation status and issues requiring prioritization.
• Leads, completes, and reviews the progress of approved projects, providing ideas and support to resolve issues that affect timely completion and achievement of project goals.
• Participates in audits and supports interactions with regulatory agencies.
• Provides technical support for investigations and the resolution of process deviations, including complex investigations.
• Assists in establishing departmental resource strategies and plans to meet business requirements and approved priorities.
• Influences project and resource direction through collaboration with business partners, manufacturing sites, and site validation teams.
• Supports the project capital plan, monthly and quarterly expenditures, cash-flow forecasts, contingencies, and scope management related to C&Q activities.
• Uses applicable project management tools—including project timelines, kickoff meetings, risk and mitigation logs, issue and action logs, decision logs, change logs, and stabilization plans—to manage projects and base-business activities.
• Supports the Engineering & Automation Manager and Engineering team in developing and maintaining the long-range financial plan (LRFP) and integrating it with regional, global, and automation strategies for C&Q.
• Supports regional and global C&Q strategies and creates a site-specific roadmap that includes standardization and integration with automation strategies.
• As applicable, provides supervision and guidance to less-experienced engineers.
• Oversees the work of contractors.
• Performs other related duties as required.

 

 

Qualifications

• Bachelor’s degree in engineering or a related scientific discipline required; advanced degree preferred.
• Four or more years of relevant experience required.
• Experience in a pharmaceutical or consumer products company preferred.
• Relevant engineering, technical, or operations experience required.
• Knowledge of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices required.
• Experience working in an FDA-regulated, cGMP-compliant environment preferred.
• Excellent verbal, written, and technical writing skills required. Bilingual proficiency in English and Spanish preferred.
• Ability to interpret and apply cGMP requirements, use mathematics and analytical skills effectively, and apply knowledge of computer system validation.
• Basic proficiency with Microsoft Office applications, including Excel, PowerPoint, and Word.
• Ability to make sound decisions based on available facts while meeting established deadlines and priorities.
• Demonstrated leadership skills.
• Strong knowledge of current quality assurance techniques.
• Ability to work independently, with minimal supervision, and under pressure.
• Demonstrated initiative and sound judgment in performing assigned duties.
• Six Sigma Green Belt or Black Belt certification preferred. FPX or PMP certification preferred.
• Professional Engineer license preferred.
• Ability to travel within and outside North America.
• Ability to work additional hours and respond to emergency calls that may require returning to the site outside regular business hours.
• Ability to support other departments and projects based on business needs.

 

What’s in it for you

$90,100.00 - $127,200.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.