Sr. Engineer, C&Q
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 sites 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 organizations 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 areas 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.
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