Validation Technical Specialist (Technical Writer)
Piedmont, SC Piedmont, SC Full-time Full-time Estimated:
$63.
2K - $80.
1K a year Estimated:
$63.
2K - $80.
1K a year 9 days ago 9 days ago 9 days ago Monday - Friday 8a - 5p (work outside of regular hour may be required) The Validation Technical Specialist is responsible for creating and/or revising technical Standard Operating Procedures (SOP), Work Instructions (WI), Preventive Maintenance (PM), and other documentation for GMP production.
Processing equipment and supporting monitoring or test equipment.
Create validation protocols and/or reports, as needed, for equipment installation and operational qualifications (IQ/OQ) or process performance qualification (PPQ).
JOB
Qualifications:
Bachelor's degree in engineering or science related field preferred (or equivalent work experience) Minimum 4 years of technical writing in a regulated cGMP environment creating Standard Operating Procedures, Work Instructions, Preventive Maintenance documents, and/or validation protocols and test scripts Solid understanding of production equipment and manufacturing processes is preferred Experience in Quality Management Systems utilizing document management and change control systems Strong understanding of cGMP regulations for pharmaceutical and/or food industry Proficient in Microsoft Word and Excel Expertise in English grammar and content editing; attention to detail is required Experience in administrative techniques and must be computer literate Efficient with time management and ability to handle multiple tasks with on time delivery Strong oral and written communication skills Ability to travel to other PLD sites or to attend off-site training, as needed POSITION
Responsibilities:
Create and/or revise technical Standard Operating Procedures (SOP), Work Instructions (WI), Preventive Maintenance (PM), and other documentation for GMP production and process equipment and other supporting monitoring or test equipment.
Create validation protocols and/or reports, as needed, for equipment installation and operational qualifications (IQ/OQ) or process performance qualification (PPQ).
Create risk assessments to document business, quality, and compliance risks associated with equipment, process, or system changes.
Review equipment manuals and collaborate with equipment SMEs (manufacturer, engineering, maintenance) to gather input and instructions for document creation.
Track progress of project assignments, attend required project meetings, and escalate issues or delays.
Route documents in a timely manner for formal approval in the Quality Management System.
Train applicable personnel on SOPs, Work Instructions.
PMs, and other documents created as needed Adhere to all company SOPs, GMPs, and quality standards in the creation, revision or training of documents.
Support validation engineers in the research, documentation, or execution of assigned validation activities, as needed.
PHYSICAL REQUIREMENTS:
Position could be exposed to various work environments such as office, production areas, laboratory, warehouse, outside, etc.
Talking, sitting, standing, walking, and climbing stairs required frequently.
Can be required to stand for long periods of time in production environment and/or working at a desk on a computer for long periods of time.
As needed, able to lift and carry light loads (NMT 20 lbs.
) for assisting with or during testing.
Some exposure to hazardous chemicals and other active chemical raw materials or ingredients is possible.
Handling and manipulating objects using hands and arms may be required.
Weekend or extended work week hours may be required based on production schedule, project timelines, or during support of validation activities.
Must be able to wear proper gowning and PPE in production areas, as required, to meet GMP and/or OSHA requirements.
Must be able to follow all safety requirements as applicable to the area and task.
Job Type:
Full-time
Benefits:
401(k) Dental insurance Flexible spending account Health insurance Paid time off Vision insurance Schedule:
Day shift Overnight shift Overtime Ability to commute/relocate:
Piedmont, SC 29673:
Reliably commute or planning to relocate before starting work (Required)
Experience:
technical writing in a regulated cGMP environment:
4 years (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
$63.
2K - $80.
1K a year Estimated:
$63.
2K - $80.
1K a year 9 days ago 9 days ago 9 days ago Monday - Friday 8a - 5p (work outside of regular hour may be required) The Validation Technical Specialist is responsible for creating and/or revising technical Standard Operating Procedures (SOP), Work Instructions (WI), Preventive Maintenance (PM), and other documentation for GMP production.
Processing equipment and supporting monitoring or test equipment.
Create validation protocols and/or reports, as needed, for equipment installation and operational qualifications (IQ/OQ) or process performance qualification (PPQ).
JOB
Qualifications:
Bachelor's degree in engineering or science related field preferred (or equivalent work experience) Minimum 4 years of technical writing in a regulated cGMP environment creating Standard Operating Procedures, Work Instructions, Preventive Maintenance documents, and/or validation protocols and test scripts Solid understanding of production equipment and manufacturing processes is preferred Experience in Quality Management Systems utilizing document management and change control systems Strong understanding of cGMP regulations for pharmaceutical and/or food industry Proficient in Microsoft Word and Excel Expertise in English grammar and content editing; attention to detail is required Experience in administrative techniques and must be computer literate Efficient with time management and ability to handle multiple tasks with on time delivery Strong oral and written communication skills Ability to travel to other PLD sites or to attend off-site training, as needed POSITION
Responsibilities:
Create and/or revise technical Standard Operating Procedures (SOP), Work Instructions (WI), Preventive Maintenance (PM), and other documentation for GMP production and process equipment and other supporting monitoring or test equipment.
Create validation protocols and/or reports, as needed, for equipment installation and operational qualifications (IQ/OQ) or process performance qualification (PPQ).
Create risk assessments to document business, quality, and compliance risks associated with equipment, process, or system changes.
Review equipment manuals and collaborate with equipment SMEs (manufacturer, engineering, maintenance) to gather input and instructions for document creation.
Track progress of project assignments, attend required project meetings, and escalate issues or delays.
Route documents in a timely manner for formal approval in the Quality Management System.
Train applicable personnel on SOPs, Work Instructions.
PMs, and other documents created as needed Adhere to all company SOPs, GMPs, and quality standards in the creation, revision or training of documents.
Support validation engineers in the research, documentation, or execution of assigned validation activities, as needed.
PHYSICAL REQUIREMENTS:
Position could be exposed to various work environments such as office, production areas, laboratory, warehouse, outside, etc.
Talking, sitting, standing, walking, and climbing stairs required frequently.
Can be required to stand for long periods of time in production environment and/or working at a desk on a computer for long periods of time.
As needed, able to lift and carry light loads (NMT 20 lbs.
) for assisting with or during testing.
Some exposure to hazardous chemicals and other active chemical raw materials or ingredients is possible.
Handling and manipulating objects using hands and arms may be required.
Weekend or extended work week hours may be required based on production schedule, project timelines, or during support of validation activities.
Must be able to wear proper gowning and PPE in production areas, as required, to meet GMP and/or OSHA requirements.
Must be able to follow all safety requirements as applicable to the area and task.
Job Type:
Full-time
Benefits:
401(k) Dental insurance Flexible spending account Health insurance Paid time off Vision insurance Schedule:
Day shift Overnight shift Overtime Ability to commute/relocate:
Piedmont, SC 29673:
Reliably commute or planning to relocate before starting work (Required)
Experience:
technical writing in a regulated cGMP environment:
4 years (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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