Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join Us as a Analytical Instramentation Specialist – Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

As part of our PPD clinical research team, you will ensure proper preventative maintenance, qualification, calibration, and operation of analytical instrumentation. You will be responsible for training and assisting, operating, and troubleshooting HPLC systems, dissolution apparatus, and other analytical equipment. Additionally, you will coordinate outside instrument vendors and service personnel

What You'll Do:

• Perform instrument calibrations and preventative maintenance of HPLC systems, dissolution apparatus, and other analytical equipment in the department.
• Write and review qualification protocols for new or relocated instruments. Review vendor qualification protocols.
• Execute and complete qualification protocols.
• Review instrument calibrations.
• Address audit comments on qualifications or instrumentation and addresses client audits relating to instrumentation.
• Research test criteria and write qualification protocols for new technologies.
• Revise, review, and write SOPs pertaining to operation, maintenance, and calibration of analytical instrumentation.
• Evaluate lab support records for compliance with SOPs, review for completeness and accuracy and reports findings.

Education & Experience Requirements:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
  In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

• Extensive knowledge on troubleshooting, maintaining, qualifying, and calibrating of several types of laboratory instrumentation
• GMP knowledge and understanding of FDA, ICH, and USP guidelines
• Ability to document analytical instrument investigations
• Sound documentation skills
• Attention to detail
• Ability to multi task
• Effective communication skills
• Ability to work in a collaborative team environment.

Working Conditions and Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment is required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

• Frequently stands, twists waists, squats, and bends neck for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.
• Frequent mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Moderate lifting (or otherwise movement, carrying, setting, and placement)of 15-30 lbs. with a maximum lift of 35 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.