Shire Lead Manufacturing Technician (2nd shift, Sun-Wed) in Cambridge, Massachusetts

Primary Role:

With minimal supervision this individual will deliver leadership and excellence in manufacturing

processing as well as scheduling to meet site demands . Oversees and executes floor

operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at

all times. Ensures efficient use of material and equipment and assigns personnel as

appropriate in the execution of day to day operations. Provide technical support through

interactions with support groups to ensure accurate and well managed transfer of process

changes/improvements to floor operations. Provide support to integrate best practices, where

appropriate, into manufacturing.

Processing

 Primary contact for troubleshooting and issue resolution or escalation

 Create and follow-up on work orders

 Communicate/ coordinate days scheduling and staffing plan

 Re-allocate staff as needed during the day (breaks, lunch, training, etc)

 Oversight and execution of all routine and critical operations as well as commissioning and validation activities

 Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)

 Responsible for floor inventory and communicating schedule changes as needed

 Monitor material consumption and coordinate all materials deliveries

 Recommend/Implement process changes/improvements or

safety/ergonomic improvements.

 Ensure work is carried out in a safe manner, notifying management of

safety issues and risks

People

 Responsible for interviewing candidates

o Provide timely feedback on staff’s performance

o Address minor personnel issues timely

o Escalate major personnel issue to the supervisor

o Ensure staff compliance with all relevant SOPs, BR, FP and safety guidelines

o Act as a role model (Lead by Example)

o Act as a resource/SME for staff

o Ensure the use of safe work practices and behaviors

 Training

o Conduct training and assess effectiveness

o Help identify training needs

o Assess staff skill sets and provide feedback to Supervisor.

o Develop training material

o Provide training

Quality

 Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause

 Implement appropriate corrective actions

 Complete action items for GMP investigations and CAPA’s

 Assist supervisor/engineer/facilities with investigations

 Revise and author Standard Operating Procedures/Batch Records

 Communicate any quality issues/concerns to Supervisor and QA

Education and Experience Requirements

Normally requires a high school diploma and 6+ years related industry experience or an

Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing

experience. Biotech Certificate and prior leadership experience preferred. Experience with

systems such as SAP, LIMS and TrackWise is a plus

Key Skills, Abilities, and Competencies

 Ability to perform manufacturing and sampling operations using aseptic technique

 Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and

general production equipment such as Autoclaves, water baths, pH/Conductivity meters

etc.

 Knowledge of cGMP’s and applicable agency regulations (such as the FDA, EMEA) to

ensure inspection readiness of department.

 Good interpersonal skills and ability to work in a team environment

 Effective communication skills to all levels throughout the organization

 Demonstrates appropriate level of adaptability, maintains positive outlook, and

demonstrates composure under pressure.

 Self motivated individual with the ability to complete and manage multiple floor activities in

an effective and compliant manner. In the absence of the supervisor they are the person

of authority.

 Expected to act on behalf of the supervisor while on the floor

 Flexibility to work according to the production schedule. This position will require weekend,

holiday and overtime work at times.

 Ability to wear personal protective equipment such as safety glasses/goggles, gloves and

safety shoes.

 Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

 Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.

 Ability to stand for 6 hours in a production suite.

 Ability to climb ladders and work platforms.

 Stooping or bending to check or trouble-shoot equipment operations.

 Ability to work around chemicals (alcohols, acids & bases).

Complexity and Problem Solving

 The incumbent will be responsible for technical problem solving and recommending

efficiency and/or operational improvements.

 Required to make process decisions, with the help of supervision and support roles,

including the trouble shooting of equipment, corrective action to process deviations.

 Individual will be required to understand operations and contact appropriate support to

ensure issues are appropriately resolved.

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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire 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/OFCCPEEOSupplementFinalJRFQA508c.pdf

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

Reasonable Accommodations

Shire 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.