Snr Calibration Specialist
Newark Metro Area, NJ
Essential Job Functions
1) Operational Activities
a. Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas.
b. Supervises vendors for Calibration, preventative maintenance, and qualification functions.
c. Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to standards.
e. Ensures all calibration, PM, and qualification records are filed appropriately after approval.
f. Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions.
g. Support the development, revision and review of written procedures for calibration, preventive maintenance and requalification of equipment.
Required Competencies Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Ability to interact effectively with laboratory, QA, and Facilities groups.
Will likely spend 60% of their time in a laboratory or manufacturing environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
Ability to work safely and effectively when working alone, or working with others.
Education & Experience:
BS in Engineering or Science related discipline preferred.
Minimum 5 years experience in GMP laboratory or manufacturing environment / regulated industry required.
Minimum 2-3 years' experience working with and troubleshooting single use biologics manufacturing equipment, such as bioreactors, chrom skids, and tangential flow filtration skids.
Experience writing and supporting deviations and investigations preferred.
Experience working with CMMS systems, mainly Blue Mountain RAM preferred.