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Validation Engineer

3 months ago

Round Lake, United States Automated Systems Full time

Validation Engineer

Contract: 6+ month contract duration

Location: Round Lake, IL - Onsite

Automated Systems, Inc. is looking for a Validation Engineer for one of our global client's Pharmaceutical Manufacturing Facility located in Round Lake, IL. The ideal candidate will handle the supporting system owners with the generation and management of documentation associated with Medical Products instrument validation and qualification activities. In this position the activity focus is on laboratory equipment and instrument systems (LE&IS) utilized in the engineering, chemistry, and information technology areas. All activities will be performed in compliance with the internal Quality System procedures and international/national regulations.

Essential Duties and Responsibilities

Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.

Serves as project lead with projects of intermediate scope and cross-functional teams.

Incumbent will be responsible for the management and archiving of approved package documents.

Incumbent may be involved with supporting system change control requests .

Mentors and provides leadership to junior team members.

Handles routine tasks timely, accurately .

Qualifications
- Basic Knowledge about industry GMP/GDP
- Expertise with Instrument/Equipment validations
- Proficient in MS Word and Excel, Computer software
- Well organized & able to multi-task
- Team oriented
- Analytical mindset
- Able to summarize and easily explain complex situations
- Solid verbal and written communication skills, including technical/business writing

Education and Experience
- BS in relevant Engineering/Science field.
- Other degrees acceptable with 3-5 years of relevant and recent validation/qualification experience.
- 3 years' experience in GMP-regulated industry, preferably medical device or pharmaceutical .
- 2+ years' experience performing instrument validations.
- GAMP experience is required .