GMP Project Manager Position Available In St. Louis, Missouri

Work Location:

St.

Louis, Missouri Shift:

Department:

LS-SC-POKN

Cherokee STL Engineering Recruiter:

Michele Lee Stabinsky This information is for internals only. Please do not share outside of the organization.

Your Role:

The GMP Project Manager is recognized as a strong technical contributor within the Engineering Team supporting facilities, maintenance, project engineering, manufacturing, and validation/QA. The Project Manager also has excellent communication skills, interpersonal skills, technical writing skills, creative problem-solving skills, and has a team-oriented attitude. To succeed in this role, you should have extensive “hands on” experience in the manufacturing environment. You will manage multiple projects concurrently, participate in cross functional teams, and manage all project aspects with technical expertise. As the Project Manager your duties will include, but are not limited to, scope development, funding approvals, concept and detailed engineering, contractor selection, project execution, commissioning and qualification, and turnover including As-Built drawings, PM plans, spare parts, asset records, C&Q documents, and all technical records.

Responsibilities:

Manage all aspects of engineering projects Supports the Management of Change process and utilizes good documentation practices Ensures GMP compliance (e.g. work order processing, good documentation practices, compliance to change management process, deviation review, CAPA assignments, etc.) Responsible for installation and maintainability of GMP utilities, facilities, and equipment such as but not limited to HVAC, compressed gases, process water, clean steam, chilled water, cleanrooms, glovebox isolators, HEPA filtration, manufacturing equipment, and control systems, etc. Monitors the performance and results of the construction team including safety, quality, reliability, and availability of assets Performs effective problem solving and root cause analysis to resolve issues, develop options, and prevent reoccurrence

Minimum Qualifications:

Bachelor’s Degree in an Engineering discipline, Chemical, Mechanical, etc. 10+ years engineering experience within a pharmaceutical, chemical, or production environment including 3+ years experience managing capital engineering projects in a GMP regulated environment

Preferred Qualifications:

Hands on experience and strong project management skills in an industrial environment Strong technical engineering skills GMP manufacturing, engineering, or compliance experience Demonstrated ability to work within a cross-functional team Ability to coach, motivate, and occasionally managing a team of peers and contractors. Excellent interpersonal and team building skills Skilled on Microsoft Suite of Applications (Outlook, Word, Excel, Project, Power Point), and other project management tools Skilled in cGMP environment Able to interpret mechanical, architectural, controls, and electrical specifications, drawing, loop diagrams, design specification, and validation requirements. Knowledge of National Electrical Code Knowledge of FDA, cGMP regulations 21 CFR Part 11, 210, and 211. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.