Technical Specialist, Manufacturing Investigations

Drive manufacturing deliverables to ensure successful commercial operations, including:

• Review deviation investigation reports to ensure World-Class levels of quality with respect to, Compliance, Logical Flow, Simplification of the Complex, Technical Completeness and Grammar
• Provide feedback and coaching to investigation report authors
• Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:
  • Lead problem solving and root-cause analysis sessions
  • Interact with Quality, Engineering and Tech Service units
  • Manage complex investigations using DMAIC tools
  • Ensure effective implementation of corrective and preventive actions
• Management of highly technical/visible Investigations
• Management of highly technical/visible cross functional projects
• Owner / point of contact for global initiatives / projects
• Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
• Train staff in general manufacturing activities 
• Collaborate in the mitigation of any Environmental, Health, and Safety (EHS) needs and risks. Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness.  This may require leading and implementing change controls
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
• Stay current with biopharmaceutical industry best practices and technologies
• Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.

Education and Experience Requirements

Bachelor degree required
Minimum eight years relevant professional experience required (GMP preferred).  Demonstrated ability to perform in a high performing workforce.

Key Skills, Abilities, and Competencies

• Excellent technical writing skills required
• Requires strong skills related to coaching and mentoring others
• Strong problem solving and analytical skills are required.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
• Possess knowledge of core manufacturing principles and support systems
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), Trackwise.
• Prefer knowledge of Lean Six-Sigma methodology
• Prefer experience in Track-wise system.

Other Job Requirements

• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment). 
• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift. 
• Must be able to climb ladders and stairs while wearing special gowning. 
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks. 
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.  
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.  
• May be working in a loud area that requires hearing protection and other protective equipment to be worn.
• Will work around chemicals such as alcohol that may require respiratory protection.
• Will handle non-hazardous, hazardous and flammable materials/chemicals.
• Must be able to work multiple shifts, including weekends. Must be able to work overtime as required. 
• May be required to work in a confined area. 
• Will work in Clean Room and cool/hot storage conditions. 
• May require immunization before performing work within the manufacturing area.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.