QC Laboratory Equipment Validation
QC Laboratory Equipment Validation
Job Number: 21-12261
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QC Laboratory Equipment Validation for our client in Devens, MA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Serves as the QC equipment owner and manages the lifecycle activities of QC laboratory equipment, including:
- Support creation of equipment User Requirement, IOPQ protocols.
- Collaborating with QC laboratories, Site Engineering, Facility Services and other departments for the commissioning and decommissioning of laboratory equipment.
- Schedule, facilitate and participate in performing the validation, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.
- Maintain equipment records in accordance with GMP requirements and written procedures.
- Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels.
- Providing basic and first-line equipment troubleshooting.
- Providing training to laboratory personnel on equipment calibration and maintenance processes, as applicable.
- Assisting management with investigations and deviations related to equipment.
- Performs other tasks as required to support the QC laboratories.
- Experience in computers and enterprise applications including LIMS and Maximo, and experience in instrument qualification in GMP environment.
- Working knowledge of Biomolecular, Analytical and Microbiology laboratory equipment such as PCR, BSCs, BACTEC, Plate reader, etc. and ability to perform basic equipment troubleshooting is desirable.
- Knowledge of USP 1058, 21CFR Part 11, GAMP 5 and other relevant industry regulations and guidance, as they relate to instrument qualification.
- Knowledge of analytical and microbiological test methods and environmental monitoring programs
- Knowledge of GMP regulations and Ability to accurately and completely understand, follow, interpret, and apply global regulatory and GMP requirements.
- Detail-oriented with expertise in problem solving and solid decision-making abilities.
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globally.
- Strong written and verbal communications skills and interpersonal skills; Advanced ability to communicate effectively with peers, department management and cross-functional peers
- Working knowledge of Data Integrity is desired.
- Bachelor's degree required, preferably in chemistry, microbiology, or related science.
- 2-3+ years of relevant experience, preferably in a regulated environment.
- Experience with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211.
- Experience and understanding of biological manufacturing processes and aseptic technique a plus.
- An equivalent combination of education and experience may substitute.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.