Manufacturing Operations Project Manager

Manufacturing Operations Project Manager

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

Job Function and

Description:

• Actively develop, support and manage projects / activities (Project Portfolio Management) as they relate to Manufacturing operations / processes:

• Effectively communicate project information between MFG floor and support functions

• Provide department project updates as required

• Review / Approve Engineering and Validation documents

• Initiate and assist with the review of project documents and facility/equipment design documents (URS/Configuration & Functional Specifications, ICV documents, etc)

• Lead and provide manufacturing support and coordination for capital projects, technology transfers, and continuous improvement efforts

• Actively support shutdown scheduling activities

• Review and approve Work Orders

• Develop project schedule

• Lead and actively engage within the Manufacturing Planning Process:

• Identify and schedule project events around manufacturing operations

• Communicate events effectively to the Scheduler and impacted groups

• Identify materials (chemicals/disposables) required to support project execution work. (i.e.: BOM exception)

• Provide input to future budget planning

• Own and Trend Quality System(s) in support of Manufacturing Operation projects

• Change Control / CAPA / Action Items

• Track status of related QS's (Initiation – Close out)

• Assign and manage action items – I.E.: SOP / Batch Record / Formulation Preparation Records to achieve project timelines

• Change Control Review Board MFG representative

• Assist in triage of open quality systems

Education and Experience Requirements:

• Bachelor's Degree (or an equivalent combination of education and relevant experience)

Requires a minimum of 5 years of experience in a Pharmaceutical Manufacturing-related field

Key Skills, Abilities, and

Competencies:

• Must be proficient with Microsoft applications, including Project, Word, Excel and Power Point

• Knowledge of biopharmaceutical manufacturing processes and equipment

• Bachelor's Degree (or an equivalent combination of education and relevant experience)

Requires a minimum of 5 years of experience in a Pharmaceutical Manufacturing-related field

Warm Regards,

Jay Kaushik

Clinical Recruiter

Integrated Resources, Inc