Senior Specialist Tech Engineering

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus 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.

What we offer:

• Competitive salaries
• Ability to earn additional income based on hours worked (Biweekly basis)
• Free High-Quality webinars provided by experts from around the world
• Committed to keeping our consultants in project continuity
• Referral Program
• Wellness Program
• Recognition Program (for employees only)
• Service Award Program (for employees only)
• Discount Program (for employees only)
• An administrative team that is oriented to providing excellent service that pursues satisfying the needs of our consultants.
• For our projects in the US, we cover travel/lodging/transportation expenses (employees only)

General Description:

PharmaLex Puerto Rico is seeking an experienced consultant who can provide support as Commissioning, Qualification (CQ) in Utilities Specialist for a variety of projects. Each qualified candidate will be responsible for coordinating commissioning, qualification and validation activities across all operational areas and ensuring activities are conducted promptly by cGMP and appropriate regulatory expectations for a regulated industry located in Manati, Puerto Rico.

SUMMARY: 

Designs and develops production layouts for the manufacturing operations to increase productivity and quality standards. Their main duties include reviewing current production schedules and processes to find potential improvements, designing the layouts of the facilities, operations, and estimating production costs. 

ROLE AND RESPONSIBILITIES: 

Documentation Changes:

1. Facilitate and manage documentation changes related to facilities and engineering processes.
2. Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
3. Collaborate with relevant stakeholders to implement documentation changes efficiently
4. Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
5. Support the documentation and records related to the pest control program.

Deviations and CAPAs:

1. Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures(SOPs).
2. Work closely with the Quality team to initiate and implement effective Corrective and Preventive Actions (CAPAs).
3. Monitor and track the progress of Deviations and CAPAs, ensuring timely closure and complianc
4. Change Control - Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
5. Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
6. Maintain Change Control records and provide support during regulatory inspections.

QUALIFICATIONS: 

• EDUCATION/LICENSES
  Doctorate degree and 2 years of Engineering experience OR Master’s degree and 6 years of Engineering experience OR Bachelor’s degree and 8 years of directly related experience
  Competencies/Skills
  • Working knowledge of pharmaceutical/biotech processes.
  • Specialized industrial chilled water, cooling towers and HVAC systems expertise.
  • Familiarity with validation and documentation processes in a highly regulated environment.
  • Deviations and CAPA management capabilities
  • Problem solving skills with the ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
  • Flexibility to work extended shift and/or weekends as per business needs.
  • Skills in the following areas: Negotiation, Persuasion, Collaboration, Project cost development, Conflict Resolution, Leadership, Team building & Schedule and Resources loading development.

PharmaLex is an Equal Opportunity Employer.

Job Types: Full-time, Contract