Pace Analytical Life Sciences - Bio Concept 13 Industrial Way Salem, NH 03079
Bio Concept, a Division of Pace Analytical Life Sciences (PLS) provides fill and finish manufacturing of aseptic aqueous products for toxicology studies and Phase I & II, as well as Phase III clinical trial studies for pharmaceutical products.
Responsible for developing and executing validation plans including critical assessment of process, establishing timelines, and generating validation protocols. Responsible for performing, coordinating and overseeing the execution, analysis of validation data, and generation of final validation reports. Provide input to update the Master Validation Plan.
Primary duties include development of validation protocols, execution of protocols analysis of the data to determine results, the preparation of a final report including conclusions and recommendations. Ensure that all projects are implemented in accordance with the agreed scope timelines, policies, and procedures. Preparation of equipment documentation: SOPs. Maintaining equipment calibration statuses and coordinating and managing vendor activities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- BS required in a scientific/technical discipline with 5+ years of experience in a validation position within the biological and/or pharmaceutical industry.
- Ability to apply GMP regulations and international guidelines to all aspects of the position
- Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
- Exceptional oral and written communication skills to all organization levels as well as clients and vendors
- Strong organizational skills; able to prioritize and manage through complex processes/projects
- Extensive experience with writing and managing investigations and risk assessments
- Ability to write reports, business correspondence and SOPs
- Ability to be hands-on and detail orientated. Very proficient in MS Office application suite as well as on validation equipment such as Kaye validators, probes and thermocouples
Education and Experience:
Bachelor's degree in engineering, AND five (5) years of experience in process, data, equipment, or facility automation; OR an equivalent combination of education, training and experience.
Required Knowledge and Skills
• Minimum of 5 years experience in a cGMP sterile fill finish environment preferred
• Strong mechanical and math skills required
• Ability to communicate well in both oral and written form
• Self-starter with the ability to work in a team environment as well as independently while handling multiple projects
• Willingness to learn and expand their knowledge and technical expertise in a motivated and fast paced environment.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Work is performed in lab and office settings. Work is subject to exposure to blood or bodily fluids, chemicals, fumes, gasses, noxious odors, and related items in a lab and environmental setting.
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity
Full-time day shift working Monday through Friday. Evening and occasional weekends hours may be required based on manufacturing schedule.