Full-Time
Manufacturing Operations Project Manager
Integrated Resources
501-1,000 employees
No salary listed
Lexington, MA, USA
In Person
 Business & Strategy (1) |
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- Bachelor’s Degree (or an equivalent combination of education and relevant experience) and a minimum of five years of experience in a Pharmaceutical Manufacturing-related field.
- Must be proficient with Microsoft applications, including Project, Word, Excel and Power Point.
- Knowledge of biopharmaceutical manufacturing processes and equipment.
- 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
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.