Sr. Manager, Project Engineering Management - Wilson, United States - Purdue Pharma

Purdue Pharma Wilson, United States

2 weeks ago

Description

This position applies project management and engineering principles to develop and implement solutions to new product transfers, operational excellence continuous improvement, equipment and facility upgrades and major system replacements.

The Engineering Project Manager is responsible for the development and implementation of cross functional projects in support of Technical Operations collaborating with the following groups: Analytical Development, Pharmaceutical Development, Package Design & Development, Quality Assurance, Manufacturing, Packaging, Supply Chain, Finance, and IT.

The Engineering Project Manager will lead multiple and major capital projects from conception to realization, maintaining scope, schedule, and budget, while ensuring compliance adherence throughout the process.

Primary Responsibilities

Develops conceptual designs and evaluates solutions to address new product transfers, new technology and manufacturing challenges. Implements solutions based on sound rational, comprehensive consultation and understanding of the requirements.
Works with functional area management to define project scope, requirements, schedule, budget, and justification sufficient to obtain funding authorization.
Develops project plans for execution, including plans for design, procurement, resources, communication, construction, and qualification.
Flawless execution of assigned capital projects, change controls, and CAPA activities.

Plans and manages projects and programs, working with team members to drive projects forward on schedule, executing on tasks and deliverables.

Participates in capital budget planning and tracking utilizing input from all areas within Technical Operations.
Responsible for organizing project kick off meetings, regular project meetings, prepares agendas, publishes minutes and action items.
Prepares work plans for each phase of the project secures resources and oversees implementation.
Develops User Requirements, Functional & Design Specifications, and qualification protocols. Participates in the execution of qualification activities.

Provide engineered designs and technical support for facility and process modifications including specifications, requests for quotation, solicitation, and evaluation of bid packages.

Operational Excellence principles must be embedded in the design and implementation packages.
Builds integrated project timelines working with team members to establish task durations and dependencies among tasks. Monitors project progress and develops a sense of urgency when key deliverables are jeopardized. Facilitates collaborative problem solving and meetings to address obstacles and manage risks.

Promptly updates project timelines and plans, publishing the revised information to clients and stakeholders when there are changes to any project.

Ensures transparent communication and decision making by influencing team organization and structure, monitoring, and providing requisite data, and escalating critical issues to the management as appropriate.

Provides technical expertise and information related to the operation and maintenance of manufacturing, packaging, and building systems equipment, and has a thorough understanding of process and production equipment.

Maintains and or modifies control system program records for system modification, upgrades, and restoration.
Fosters teamwork; strives to maintain an environment of openness and trust.
Potential for management of project engineers within the technical services organization.
Ensure adherence with Federal, State and City Codes. Secure permits and facilitate inspections.

Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.

Performs other related assignments and duties as required and assigned.

Education And Experience Requirements

Requires a B.S.

in Engineering with at least 10 years of progressive experience in a pharmaceutical or biotechnology manufacturing environment and at least 5 years of experience in project management.

Necessary Knowledge, Skills, And Abilities

Demonstrated project management and leadership skills. Able to manage multiple contractors in support of large facility projects. A current and detailed knowledge of cGMPs and FDA guidelines. Knowledge of building codes and standards. Experience with the installation, qualification of manufacturing, packaging, facility, and utility equipment in a regulated industry. Expertise with reading and understanding schematics, P&IDs, and other design documents. Ability to conceptualize and execute solutions to problems. Automation system (i.e. PLC, SCADA) knowledge in areas of specifying and troubleshooting.

Expert knowledge of Microsoft Project, along with proficient use of Microsoft Word, Outlook, Teams, and Excel. Familiar with AutoCAD. Project management and business acumen required. PMP Certification preferred. SAP experience.

Supervisory Responsibilities (if Applicable)

There are no direct supervisory responsibilities.

Physical/Environmental

Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.

While sitting for an extended period of time on a routine basis, incumbent may use the following equipment:
Personal computer, telephone/ other voice communication devices, copier, fax or other specialized equipment used in an office setting.
Individual may move various items (i.e boxes, carts, files, etc) by hand or manual hand carts.
Must be able to work a 10 hour per day/4-day work week; 40 hours per week.

Additional Information

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions.

Additionally, the company may revise the job description at any time.

Purdue Pharma does not sponsor or facilitate any U.S. work/intern or training authorization for this position.

All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.

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