Job Description

Quality Assurance, Equipment Validation Engineer, Lead

Requisition ID: 155426BR

When you join us at Thermo Fisher Scientific, you2019ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The role is responsible for Equipment Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices. This position will be based out of Carlsbad, CA.

How will you make an impact?

We are looking for a self-driven, experienced and resourceful Lead Equipment Validation Engineer to develop and support the successful implementation of manufacturing laboratory equipment.

What will you do?

* Develops and supports execution of equipment validation protocols and associated reports (IQ, OQ, PQ) while adhering to the site Change Management process.
* Develops written procedures for equipment calibration and preventive maintenance of equipment, where applicable.
* Supervises vendors for qualification functions, where necessary.
* Support manufacturing laboratory equipment implementation including but not limited to IOPQs, user requirement specifications, traceability matrices, etc.
* Maintains all qualified and validated equipment in compliance with policies, guidelines and procedures.
* Provides technical support and guidance on equipment qualification issues
* Manage projects of varying scope and complexity.
* Drive a culture of continuous improvement by employing Practical Process Improvement concepts and managing metrics, tiered management system escalations, reporting and communicating internally to Senior Leaders and diverse audiences.
* Provide significant knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks.

How will you get here?

Education

* Bachelor2019s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

* Minimum of 3-5 years2019 experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
* Minimum of 1 year of management experience in a complex, biotech or medical device manufacturing environment.

Knowledge, Skills, Abilities (Required)

* Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders including Manufacturing, Technical Operations, Equipment Services, etc..
* Strong leadership ability with the capability to leverage work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.
* Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Trained in Lean Sigma/Six Sigma processes.
* Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
* Compliance with regulated quality management system standards (e.g., 21 CFR Part 820, 21 CFR part 210/211, ISO 9001, ISO 13485, MDSAP, ICH Q7, Eudralex volume 4 requirements and excipient manufacturing regulations).
* Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
* Global Systems e.g. TrackWise, AGILE, E1, LIMS
* Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).

Knowledge, Skills, Abilities (Preferred)

* Experience with biological manufacturing processes.
* Project Management advanced experience.
* Certified Lean Professional or Six Sigma experience

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected