Sr. Engineer, C&Q

Kenvue•Lititz, PA

22h•$90,100 - $127,200•Onsite

About The Position

The Senior Engineer, Commissioning and Qualification (C&Q) supports and completes site projects requiring C&Q and provides technical guidance on C&Q standards, procedures, risk assessments, regulatory requirements, practices, and execution. The role contributes C&Q requirements to the Product Life Cycle process and collaborates with Engineering, including the Solids and Packaging Technology Platforms, Quality, and Manufacturing to strengthen C&Q practices, procedures, and performance measures. As needed, the Senior Engineer supports or leads implementation of site, regional, and global project and automation strategies affecting C&Q processes. The position 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. It presents C&Q execution strategies, deviations, outcomes, and metrics to applicable site or regional governance bodies and participates in other meetings as needed. The role also helps manage projects and base-business activities, supports project financial planning, contributes to site-specific C&Q roadmaps, and may guide less-experienced engineers and oversee contractors. The position is based fully onsite in Lititz, Pennsylvania. It requires the ability to travel within and outside North America, work additional hours, and respond to emergency calls that may require returning to the site outside regular business hours.

Requirements

Bachelor’s degree in engineering or a related scientific discipline.
Four or more years of relevant experience.
Relevant engineering, technical, or operations experience.
Knowledge of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices.
Excellent verbal, written, and technical writing skills.
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.
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.

Nice To Haves

Advanced degree.
Experience in a pharmaceutical or consumer products company.
Experience working in an FDA-regulated, cGMP-compliant environment.
Bilingual proficiency in English and Spanish.
Six Sigma Green Belt or Black Belt certification.
FPX or PMP certification.
Professional Engineer license.

Responsibilities

Complete required GMP and assigned-curriculum training, follow applicable procedures, demonstrate integrity, and promptly identify and report deviations while supporting a commitment to doing the job right the first time.
Conduct negotiations and activities according to current business conduct principles.
Comply with EHS Program and ISO 14001 requirements, complete EHS training, maintain a safe work area, follow applicable safety and environmental procedures, and report unsafe conditions, risks, incidents, and accidents.
Participate in waste-reduction, recycling, energy-reduction, environmental protection, ergonomic, and other applicable EHS initiatives; contribute to organizational EHS goals and objectives.
Maintain in-depth knowledge of current industry validation practices and ensure established procedures are followed during C&Q activities.
Participate in and, as applicable, lead cross-functional teams to complete projects and establish consistent, harmonized validation processes and procedures across company manufacturing sites.
Take a leadership role in company forums focused on validation standards and guidelines, as applicable.
Author and approve standard operating procedures and validation documents as the technical subject-matter expert.
Document site C&Q activities consistently and promptly in the Validation Master Plan and provide metrics on performance against documented plans.
Inform senior management of validation status and issues requiring prioritization.
Lead, complete, and review approved project progress; provide ideas and support to resolve issues affecting timely completion and project goals.
Participate in audits and support interactions with regulatory agencies.
Provide technical support for investigations and resolution of process deviations, including complex investigations.
Assist in establishing departmental resource strategies and plans to meet business requirements and approved priorities.
Influence project and resource direction through collaboration with business partners, manufacturing sites, and site validation teams.
Support the project capital plan, monthly and quarterly expenditures, cash-flow forecasts, contingencies, and scope management for C&Q activities.
Use applicable project management tools, including 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.
Support the Engineering & Automation Manager and Engineering team in developing and maintaining the long-range financial plan and integrating it with regional, global, and automation strategies for C&Q.
Support regional and global C&Q strategies and create a site-specific roadmap incorporating standardization and integration with automation strategies.
Provide supervision and guidance to less-experienced engineers, as applicable, and oversee contractor work.
Support other departments and projects based on business needs and perform other related duties as required.