Engineering Investigation Specialist-MS&T - Temp (On-Site) presso Tolmar

Purpose and Scope

The Investigation Specialist is a technical leader within the MS&T department with a primary role in investigating and documenting calibration, equipment, facility, packaging, or validation failures and deviations from procedures. The role requires a person with industry experience in investigations who will contribute specific compliance knowledge along with investigational and technical writing skills to the Investigations group.  

Essential Duties & Responsibilities

• Assume compliance leadership role in the MS&T Department for management and peers. Includes dissemination of specific knowledge to the MS&T group and technical leadership in Deviation and Laboratory Investigation Quality Events.
• Conduct complex and challenging deviations investigations, lab investigations, and trend investigations requiring a high level of expertise and in-depth knowledge of work performed at Tolmar.
• Troubleshoot and take immediate action of quality events in real time with in-depth understanding of product and process impact.
• Create SMART CAPAs and Effectiveness Checks, resulting in the reduction of deviations and recurrences.
• Act as a primary technical resource and point of contact for deviations, lab investigations, and audit activities.
• Accountable for maintaining a positive atmosphere of teamwork, camaraderie and respect towards co-workers.
• Serve as the departmental point of contact for all EQMS (electronic quality management system), needs in Veeva.
• Interact closely and effectively with project teams and across departments.
• Provide input and guidance as necessary to junior-level technical writers and investigators.
• Assist departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of technical, organizational, and project management skills.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities 

• Strong grasp of Root Cause Analysis and 5 Whys methodology.
• Understanding of ALCOA+ and data integrity principles.
• Proven ability in cross functional groups to solve problems, gain consensus, and drive effective improvement.
• Ability to grasp and enhance the technical expertise required for current and new products/processes in order to support Engineering functions as per business needs.
• Thorough knowledge of cGMP and application to pharmaceutical manufacturing.
• Basic knowledge of GDP and QA/QC principles and concepts.
• Strong knowledge of word processing, graphics and spreadsheet programs.
• Excellent organizational, interpersonal and leadership skills.
• Ability to manage and prioritize multiple projects and tasks, demonstrating strong organization and time management skills.
• Strong oral and written communication skills.
• Ability to work on short and long-term projects simultaneously and meet timelines.
• Ability to work well independently and with others.

Core Values

This position is expected to operate within the framework of Tolmar’s Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• ​Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​

 Education & Experience

• Bachelor’s degree preferred; preferably in an engineering or scientific discipline.
• Three or more years of investigation experience.
• Four or more years of experience in a pharmaceutical or regulated industry in quality assurance, production, engineering, or formulation development.
• Experience with statistical trending and database programs preferred.

 Working Conditions

Working conditions are typical for an office environment.

Compensation and Benefits

• Pay range: $46.00 to $48.00 hour depending on experience
• Benefits summary:  https://www.tolmar.com/careers/employee-benefits 

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. 

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.