CQV Engineer

Job Role: CQV Engineer

Location: Summit, NJ

• Knowledge of cGMP, GXP, GAMP, and 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 where individual initiative, accountability to the team, and professional maturity are required.

• 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.

• Highly 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.

• Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.

• Ability to interact effectively with laboratory, QA,and Facilities groups.

• BS in Engineering or Science related discipline preferred.

Minimum 5 years’ experience in FDA-regulated industry

• Experience working directly with bench top manufacturing and laboratory equipment (cell counters, liquid handlers, Flow Cytometry, etc.) preferred.

• Knowledge of cGMP in the pharmaceutical industry

• Excellent computer skills including knowledge of calibration management and environmental monitoring systems

• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.

Please share your resumes at chaitanya@starkassociatesllc.com (or) Contact: 848-277-1023