Current Jobs


Top 100 Jobs
Category Position Location Date Posted Close Date
Contract SAP Quality Management New Brunswick , New Jersey 29 Apr 2021
Full Time Architect Remote , New Jersey 21 Apr 2021
Contract SAP Analyst North Brunswick , New Jersey 29 Apr 2021
Contract Auditor Nassau Park, New Jersey 29 Apr 2021
Contract Associate Scientist Devens, Massachusetts 16 Apr 2021
Contract Customer Service representative Liberty Lake, Washington 12 May 2021
Contract Customer Service representative Plano, Texas 12 May 2021
Contract Drug Safety Gaithersburg, Maryland 23 Apr 2021
Contract Equipment Engineer Warren, New Jersey 16 Apr 2021
Contract Executive Assistant Swift Water , Pennsylvania 23 Apr 2021
Contract FACILITIES MAINTENANCE - FACILITIES SPECIALIST Phoenix , Arizona 16 Apr 2021
Contract Manufacturing - Stability Scientist Seattle , Washington 16 Apr 2021
Contract Marketing Lawrenceville, New Jersey 21 Apr 2021
Contract Phone banker / Personal banker / Bank Teller - Retail Banking Pasadena, California 21 Apr 2021
Contract Project Coordinator New Brunswick , New Jersey 23 Apr 2021
Contract Sales & Marketing Remote , New Jersey 12 May 2021

Job Title: Equipment Engineer
Location: Warren
State: New Jersey
Close Date None
Position Description:

Equipment Engineer

Required Qualifications:

Education & Experience:
* BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
* 7 years of combined experience in FDA-regulated GMP lab environment
* Must have experience validating and using common lab equipment and stand-alone computerized lab systems
* Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas.
* Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent
* Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent.

 

Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:

* Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
* Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements
* Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems
* Strong experience writing and executing system validation & equipment qualification documents
* Ability to interact effectively with laboratory personnel, QA, and Facilities groups
* Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong 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
* Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation
* Innate ability to learn new software as required for equipment qualification and system validations.
* Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met.

Regards,

Nilesh Katkar

(Direct)609-681-5752 / 609-454-3209 ext-223 / (cell) 732-207-9798  / (Fax) 609-356-0312

Desired Qualifications:

Education & Experience:
* BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
* 7 years of combined experience in FDA-regulated GMP lab environment
* Must have experience validating and using common lab equipment and stand-alone computerized lab systems
* Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas.
* Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent
* Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent.

 

Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:

* Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
* Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements
* Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems
* Strong experience writing and executing system validation & equipment qualification documents
* Ability to interact effectively with laboratory personnel, QA, and Facilities groups
* Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong 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
* Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation
* Innate ability to learn new software as required for equipment qualification and system validations.
* Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met.

Regards,

Nilesh Katkar

(Direct)609-681-5752 / 609-454-3209 ext-223 / (cell) 732-207-9798  / (Fax) 609-356-0312

Apply for this Job
Return to Job Listing