Specialist 3 - Quality - Pioneer Data Systems
Lititz, PA 17543
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Lititz, PA is currently looking for a Lab Equipment Maintenance Specialist to join their expanding team.
Job Title: Lab Equipment Maintenance Specialist / Pharma Industry
Duration: 24 months contract
Location: Lititz, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Notes from Manager about position:
Length of position can be up to 2 years in full
Onsite 100% at Lititz location
Exp in maintenance of laboratory equipment
Exp in troubleshooting of analytical equipment and microbiology equipment
Will work on work orders for maintenance of equipment
Will perform data entry on all tasks performed
Bachelor's Degree is required
At least 3 years of prior experience
Metrology experience and/or Analytical Lab experience
Knowledge of the system Empower
General Summary:
ICMS Specialist Job Description
Under moderate supervision performs calibration and preventative maintenance on lab equipment and performs IQ/OQ on equipment.
Adheres to Company policies, governmental and regulatory requirements and maintains adequate lab supplies.
Duties & Responsibilities:
1. Perform data entry for PM and CAL tasks performed by laboratory employees. Initiate change request work order.
2. Provide consistent support for all laboratory instruments to ensure acceptable levels for performance, reliability, user satisfaction and integration with other systems.
3. Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities.
4. Serve as a local system admin for computerized lab systems.
5. Support the purchase, install and equipment qualification of new laboratory equipment (Microbiology and Analytical Labs, QC Inspection).
a. Write validation test scripts and protocols.
b. Execute validation protocols.
6. Lock Out Tag Out for lab equipment and equipment operating/calibration/preventative maintenance instructions meeting procedural standards.
7. Author SOPs and Job Aides associated with laboratory equipment or related processes.
8. Operate within the confines of departmental SOPs and regulatory guidance.
Additional Responsibilities:
1. Communicates potential problems and issues to the Team Leader in a timely manner.
2. Demonstrates competent computer use (entry/retrieval).
3. Adheres to regulatory, company and departmental requirements.
4. Ensure quality and compliance in all my actions by:
All employees
Attend GMP training on the schedule designated for my role and as appropriate for my role.
Adhere to strict compliance with procedures applicable to my role.
Exercise the highest level of integrity in the tasks that I perform.
In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
Embrace a behavior of employee involvement and commitment to doing the job right the first time.
Qualifications:
1. B.S. Degree in Analytical Chemistry, Engineering or related sciences with at least 3 years of industry experience.
2. Experience working within a GLP or GMP laboratory.
3. Experience maintaining laboratory equipment such as particle size analyzers, X-ray fluorescence Detectors, Density Meters, Refractometers, or Halls Thickness Gauges.
4. Experience handling computer system validations of laboratory systems preferred.
5. Computer skills with utilization of SDMS, Compliance Builder, and Empower. Experience with Maximo, SAP and LIMS preferred.
6. Experience maintaining laboratory equipment (i.e., IC, GC, UPLC) or other specialized computerized systems.
7. Capable of working independently under moderate supervision.
8. Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators.
Our client, a world-leading Pharmaceutical Company in Lititz, PA is currently looking for a Lab Equipment Maintenance Specialist to join their expanding team.
Job Title: Lab Equipment Maintenance Specialist / Pharma Industry
Duration: 24 months contract
Location: Lititz, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Notes from Manager about position:
Length of position can be up to 2 years in full
Onsite 100% at Lititz location
Exp in maintenance of laboratory equipment
Exp in troubleshooting of analytical equipment and microbiology equipment
Will work on work orders for maintenance of equipment
Will perform data entry on all tasks performed
Bachelor's Degree is required
At least 3 years of prior experience
Metrology experience and/or Analytical Lab experience
Knowledge of the system Empower
General Summary:
ICMS Specialist Job Description
Under moderate supervision performs calibration and preventative maintenance on lab equipment and performs IQ/OQ on equipment.
Adheres to Company policies, governmental and regulatory requirements and maintains adequate lab supplies.
Duties & Responsibilities:
1. Perform data entry for PM and CAL tasks performed by laboratory employees. Initiate change request work order.
2. Provide consistent support for all laboratory instruments to ensure acceptable levels for performance, reliability, user satisfaction and integration with other systems.
3. Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities.
4. Serve as a local system admin for computerized lab systems.
5. Support the purchase, install and equipment qualification of new laboratory equipment (Microbiology and Analytical Labs, QC Inspection).
a. Write validation test scripts and protocols.
b. Execute validation protocols.
6. Lock Out Tag Out for lab equipment and equipment operating/calibration/preventative maintenance instructions meeting procedural standards.
7. Author SOPs and Job Aides associated with laboratory equipment or related processes.
8. Operate within the confines of departmental SOPs and regulatory guidance.
Additional Responsibilities:
1. Communicates potential problems and issues to the Team Leader in a timely manner.
2. Demonstrates competent computer use (entry/retrieval).
3. Adheres to regulatory, company and departmental requirements.
4. Ensure quality and compliance in all my actions by:
All employees
Attend GMP training on the schedule designated for my role and as appropriate for my role.
Adhere to strict compliance with procedures applicable to my role.
Exercise the highest level of integrity in the tasks that I perform.
In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
Embrace a behavior of employee involvement and commitment to doing the job right the first time.
Qualifications:
1. B.S. Degree in Analytical Chemistry, Engineering or related sciences with at least 3 years of industry experience.
2. Experience working within a GLP or GMP laboratory.
3. Experience maintaining laboratory equipment such as particle size analyzers, X-ray fluorescence Detectors, Density Meters, Refractometers, or Halls Thickness Gauges.
4. Experience handling computer system validations of laboratory systems preferred.
5. Computer skills with utilization of SDMS, Compliance Builder, and Empower. Experience with Maximo, SAP and LIMS preferred.
6. Experience maintaining laboratory equipment (i.e., IC, GC, UPLC) or other specialized computerized systems.
7. Capable of working independently under moderate supervision.
8. Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators.
Source : Pioneer Data Systems