Specialist Manufcturing (Process Owner)

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

JOIN OUR TEAM!

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 in 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:

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems

FUNCTIONS

pplied Process Expertise
1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
3. Provide troubleshooting support.
4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Process Monitoring
1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
2. Provide support of timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA
1. Ensure that all Non-conformances are triaged within the established goal.
2. Responsible for authoring investigation reports.
3. Responsible for execution of corrective actions.
4. Responsible for managing NC/CAPA closure within established goal.
5. Monitor and communicate incidents trends.
6. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation
1. Assist with generation of process validation protocols and reports.
2. Assist with the execution of the process validation.
3. Support collection and analysis of process validation data.

Regulatory
1. May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications
1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control
1. Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives
1. Participate on the assessment or implementation of special projects or initiatives.

** Other functions may be assigned.

QUALIFICATIONS / REQUIREMENTS NEEDED

Detailed technical understanding of bioprocessing unit operations.
- Skilled in performance of GMP production operations.
- Regulatory knowledge and interactions.
- Participate and help lead cross-functional teams.
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
- Organizational, technical writing and presentation skills.
- Basic project management skills.
- Basic knowledge of control charting.
 

EDUCATION:

- Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.

PharmaLex is an Equal Opportunity Employer.
Administrative Shifts, availability for training and validations may appply for 2nd and 3rd shifts if needed. 


 

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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