Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and youll be supported in achieving your career goals.

How will you make an impact?

This position will be responsible for oversight of cleaning validation activities and projects for Thermo Fisher Scientific CRO Operations manufacturing facilities. Technical duties include assist in implementing validation strategy, adhering to domestic and international GMP regulations, ownership and oversight of cleaning characterization activities and TOC swab methods, incorporating continuous improvements into validation activities and policies, and participate in regulatory inspections.The scope of responsibility encompasses the product life cycle for existing commercial small molecule products as well as emerging products. Creates, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues. Implements systems to ensure compliance with new and changed regulations. Performs activities across key quality functions to support the business units.

What will you do?

* Serves as a primary resource for validation activities associated with cleaning validation and additionally serve as a resource for other qualification activities within the engineering team for equipment, computer system, and packaging equipment automation validation.
* Prepares, reviews and approves production, validation, and/or procedures, and rationales.
* Supports systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.
* Participates as the validation representative in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance and interdepartmental consistency within the validation program.
* Maintains current knowledge and serve as a technical resource for emerging trends and technologies.
* Coordinates and provides training and/or opportunities for career development of others. Identifies training needs and assists develop training programs.
* Performs other duties as assigned.

How will you get there?

* B.S. in Engineering discipline (Chemical, or related).

Experience:

* One to two years experience in the pharmaceutical industry.
* Excellent computer skills (Microsoft Word, Excel, Project, Power Point)
* Superior writing skills, strong accuracy, attention to detail, and technical knowledge.
* Experience with a variety of pharmaceutical manufacturing equipment.

Equivalency:

* Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP ) Strong interpersonal and communication skills. Ability to effectively collaborate with others to achieve team goals and expectations. Familiarity with a variety of concepts, practices and procedures. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move, push) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.