Validation Engineer

Looking for a New Validation Engineering Role?

Actalent has the one for You!

Actalent's client is currently hiring for a Validation Engineer to support the Validation efforts in establishing both validation and re-validation policies and programs. In this role you will work closely and cross-functionally with internal departments to support a wide range of activities assuring that processes, systems, facilities and equipment comply with accepted current good manufacturing practices utilizing a life-cycle approach. The role has a high degree of FDA and ISO 13485 knowledge is critical to this position. You will be handling sensitive and/or confidential documents and information will be routine.

Key Duties and Responsibilities:

• Develop, review, approve and execute validation documentation including, but not limited to: URS, FDS, DOE, FAT, IQ, OQ, PQ, and VQs.

• Maintains requalification schedule for facilities, equipment and processes.

• Responsible for the maintenance and implementation of Validation Master Plan Schedules.

• Arranging, planning, managing and executing installations, operations and performance qualifications of packaging, processing, critical utilities, laboratory instruments and computer systems.

• Scheduling, planning, managing and executing process validation studies and authoring related plans, summary reports and protocols.

• Reviewing and approving validation project documentation.

• Coordinating and interfacing with the process unit heads, quality and engineering groups in order to assure successful project execution.

• Leading and coordinating cross-functional teams for project validation.

• Prioritizing, managing and executing validation projects utilizing project management methodologies.

• Supporting the development of best and proven validation practices in the validation department, based upon current industry guidelines and practices.

• Maintaining relevant standard operating procedures for ensuring compliance with the company's policies and FDA regulations.

• Supporting regulatory submissions and also regulatory agency inspections whenever required.

• Participating and presenting continuous improvements in the validation department.

• Coordinate, manage and where required, perform the following:

• Risk assessments for validation testing with participation of QA, RA, Production, R&D , and Engineering

• Protocol development/ review/approval, protocol execution, discrepancy and report generation

• Training of personnel performing validation activities

• Support development of other lifecycle documentation including user/ system requirements, risk assessment, design qualification, review and approve site procedures

• Resolution of test failures and deviations; ensure sound compliance rationale is developed and documented

Skills:

• ISO 13485

• Equipment Validation

• Process Validation

• Computer Validation

• Six Sigma

• Lean Manufacturing

• Pq

• Oq

• Iq

• Validation

• Validation protocols

• Pharmaceutical

• Gmp

Job Requirements:

• Bachelor's Degree (BS or BA) in a science (i.e. math, chemistry, biology) or engineering related field

• Experience with computer validation a PLUS

• Six Sigma Certification or other related - PLUS

• Excellent working knowledge of cGMP requirements on validation methods and principles including ISPE, GAMP guidelines and FDA, 21 CFR Part 11 Electronic Records and Signatures requirements.

• Working knowledge of Quality Engineering tools, such as Six Sigma and Lean Manufacturing preferred.

• Able to handle multiple, complex projects and work independently.

• Ability to build relationships with customers and internal departments.

Employee Perks:

• Paid Weekly

• Medical, Dental, Vision, 401K plans

• Abenity Discount Program

• Udemy Courses

• Work Life Balance

• PTO/Paid Holiday's

Experience Level:

1-3+ years related experience in the pharmaceutical or medical device industry.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.