Project Manager - Cleaning Validation

Juncos, Puerto Rico, Puerto Rico
Full Time
Senior Manager/Supervisor

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PharmaLex is a successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, and a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Job Description

Monitors program/project/system status, budgets, and timetables. Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures. Gathers and compiles information for reports. Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding. Designs, develops, analyzes, troubleshoots, and provides technical skills during research and/or product development projects. Plans and coordinates larger-scale engineering projects or several medium or small projects while acting as a technical specialist for a specific section. Maintains a thorough knowledge of new developments and technology. Monitors projects and recommends changes to improve operating efficiency. 

Position Responsibility: 

- Review contract requirements in the areas of request for proposals (RFP) in partnership with Global Strategic Sourcing and process change orders as required through the system (Efinity).
- Assess project progress through the preparation of the monthly Total Cost Management (TCM) report by project through eBuilder software; this must be reviewed with the Project Manager for approval.
- Prepare monthly projects accruals.
- Perform a Monte Carlo risk assessment using project risk register to determine project contingency.
- Perform a quarterly capital project latest estimate (LE) and the annual budget plan for capital and expense expenditures.
- Establish and manage cash flow projections.
- Audit capital project invoices prior to payment.
- Work cross-functionally within Finance, Global Strategic Sourcing and Corporate business organizations to resolve any issues with vendors.
- Participates in meetings and coordinates cost meetings with project staff.

Needed qualifications: 

  • Leads and / or participates in development, qualification and validation activities for product or technology transfers Cleaning validation, Change Control and Automation experience 

  • Trains production personnel, and other engineers/technicians. 

  • Ensures compliance with company policies, programs, and procedures, regarding to government and regulatory agencies' regulations (e.g. EEO, ADA, ISO, QSR). 

  • Schedules and coordinates major segments of complex projects to meet cost and time objectives. 

  • Conducts feasibility studies, determines manpower and cost estimates, and develops engineering criteria. 

  • Designs, develops, analyzes, troubleshoots, and provides technical skills during research and/or product development. 

perform other position-related duties as assigned.

PMP Certification. 

Knowledge and Skill Requirements:

  • Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
  • Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities
  • Thorough knowledge of cGMP/FDA regulations
  • Ability to drive change and motivate others toward a common vision
  • Ability to lead teams that are not direct reports
  • Demonstrated facilitation, problem solving, and analytical skills
  • Understanding of cGMP regulation and quality management systems for pharmaceutical operations
  • Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management
  • Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills

Position Requirements 

  • Doctorate degree and 2 years of directly related experience 

  • OR Master’s degree and 4 years of directly related experience 

  • OR Bachelor’s degree or and 6 years of directly related experience 

  • Practical project management software and spreadsheet skills, proficient computer operation skills. 

  • Fluent business English and Spanish, written and oral 

  • Understanding and experience with Ariba Sourcing and Contracting Modules. 

  • Experience with SAP, Trackwise and Project management tools preferred. 

  • Highly proficient with MS Office, including Excel, Word, PowerPoint, and Microsoft Projects 

  • Change Control  

  • Project Management (Project Timelines, etc.) 

  • Document Review 

PharmaLex is an Equal Opportunity Employer.

Job Types: Full-time, Contract

Work: In person

Pay Rate: 40ph 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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