Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.) Job Description Summary: Supervise the activities of the calibration (Metrology) group in the performance & validation of all new and existing analytical equipment according to a set schedule and current Patheon Standard Operating Procedures (SOPs), Good Manufacturing Practices, Good Laboratory Practices (GLPs) and corporate quality standards. Provide support in monitoring business process performance measures and advise management of potential quality or regulatory issues that may affect product quality of regulatory compliance. Essential Functions: Supervises a Team of 4-6 Scientists who are responsible for the execution of laboratory instrumentation preventative maintenance, qualification and validation activities. Ensures instruments are calibrated and preventative maintenance is performed as scheduled. Assigns tasks within the group to ensure completion. Performs routine calibration and validation of all equipment according to schedule. Assigns tasks within the group to ensure completion. Updates calibration, performance verification and preventative maintenance SOPs to keep current with Good Manufacturing Practices requirements. Coordinates external outside calibration and preventative maintenance services, if required. Performs Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) on all new equipment. Maintains the calibration and preventative maintenance schedules for each new and existing piece of analytical equipment. Sets up systems to continually improve the metrology, lab assistants and QC laboratories to ensure increasing effectiveness of service. Performs and completes performance appraisals throughout the year. Selects, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures. Performs alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS Education: Minimum Bachelor of Science (B.Sc.) in Chemistry or a science related to pharmaceutical analysis Experience: Proven experience in quality control/analytical development within the pharmaceutical industry Previous Supervision and/or leadership and training experience Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Previous method and analytical instrumentation validation experience in the pharmaceutical industry. Possesses a highly developed quality, regulatory and production attitude including an appreciation for client service and contract manufacturing. Excellent knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Well organized and detail oriented. Strong interpersonal and communication skills (both oral and written). Demonstrated leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations. Experience with Microsoft Office Applications. Proficiency in the English Language. Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) 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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
