Description
The Sr Specialist/Specialist, Manufacturing Compliance position offers a base salary typically between (60,000) and (97,000) or (90,000) and (147,000).? There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. ?The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.
Individual contributor responsible to manage investigations, own change control records and lead projects in support of Manufacturing Operations (DS and DP). This position will support in the planning, monitoring, reporting of deviations, change controls and improvement projects. This position is responsible to own deviation investigations and change control records. Accountable for continuous process improvements and efficiency gains. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees
Duties & Responsibilities
Manages small to medium investigations, change control records and projects under supervision. Responsible for achieving deviation, change control and project goals including timelines and scope. Creates schedules and monitors the deliverables against the timeline.
Thoroughly investigates simple to moderate deviation events utilizing root cause analysis techniques. Utilizes technical writing strategies to ensure content is clear, concise, and complete. Leads team to evaluate pertinent aspects involved in determining deviation scope, impact, and to perform necessary evaluations to support conclusions. Ensures corrections are initiated to address root cause and contributing causes discovered during investigation.
Responsible for maintaining inspection readiness within Manufacturing in the following ways:
Identify, propose, and executes compliance process and procedural changes to reduce deviations.
Implements corrective actions.
Leads area walk through for housekeeping
Under supervision analyze data relative to defined KPI. Consult with SME´s to make recommendations for improvement based upon the data gathered.
Delivers training for Manufacturing Operations, under supervision. Completes all required training on time.
Under supervision, initiates lean manufacturing techniques in order to actively reduce cycle times of deviations, change controls and CAPA. Identifies areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.
Specialist Requirements
Bachelor´s degree from an accredited institution, preferably in a science or engineering related field plus three (3) years´ experience in cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
Associate´s degree from an accredited institution plus five (5) years of manufacturing experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility
RequiresA High School Degree, with six (6) years´ experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task. Experience is necessary but mastery isn´t required from the specialist
Projects are cross functional and the project scope is limited. The specialist should be able to independently influence peers to achieve a common goal
Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)
Time management: Must be able to multi-task and be organized
Experience in biotech, pharmaceutical manufacturing or device manufacturing is a requirement. Preferably experience being a manufacturing operator or technician
Composure around management: Specialist must remain cool under pressure, have demonstrated confidence in speaking at team meeting and have some experience presenting to Sr. Management and or auditors
General understanding why a change control process is necessary and important. Specialist doesn´t need direct experience in generating change controls.
Ensures compliance with manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, and Safety) and Company Policies, Procedures, Goals and Objectives. Demonstrates good knowledge of GMP, FDA and European regulations. Follow all relevant department policies, procedures, SOP and other requirements during project execution and act at all times within the BI standards/ethics policies.
Sr Specialist Requirements
Bachelor's degree from an accredited institution, preferably in a science or engineering related field plus three (3) years of experience in cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
Also acceptable: Associate degree from an accredited institution plus six (6) years of experience or High School Diploma plus eight (8) years of experience as listed above.
Significant experience leading meetings of various scope and size. This skill should be mastered.
Projects are cross functional, and the project scope is moderate. The Sr. Specialist should be able to independently influence peers and managers to achieve a common goal and overcome obstacles.
Demonstrated ability in technical writing
Time management: Mastery in multi-tasking
Experience in biotech, pharmaceutical manufacturing or device manufacturing is a requirement. Preferably experience being a leader.
Composure around management: Sr. Specialist must remain cool under pressure, have demonstrated confidence presenting to Sr. Management and have some experience presenting/speaking to auditors to defined program of limited scope (e.g. deviations, change control records, general operational procedures)
Experience with writing deviations, managing change control process, creating trend reports and general knowledge on what aspects are important to include in quality system records of various complexity.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
