Operations Specialist III - Baton Rouge, United States - Mallinckrodt Pharmaceuticals

Description

Job Title
Operations Specialist III
Requisition
JR Operations Specialist III (Open)
Location
CC-Port Allen - USA502
Additional Locations
Baton Rouge, LA, Port Allen, LA
Job Description

The Operations Specialist II is responsible for performing production activities in compliance with applicable government regulations and guidelines as well as with company policies and procedures.

The Operations Specialist II is a senior level operator and is expected to possess a strong technical knowledge of manufacturing operations.

Essential Functions

• Ensure safe task execution and report safety concerns promptly.
• Complete required training for production tasks.
• Carry out daily production activities, including preparation, filling, and packaging.
• Follow daily and weekly production schedules.
• Communicate schedule changes with leads and QA to maintain production requirements and safety standards.
• Adhere to production batch records and procedures, ensuring compliance with policies and cGMPs.
• Procure components for manufacturing operations and conduct inventory checks to prevent interruptions in production.
• Monitor logbooks daily for compliance.
• Perform equipment cleaning and maintenance as needed.
• Assist in process deviation investigations with QA.
• Participate in Continuous Improvement initiatives and support validation lifecycle activities.
• Provide assistance across the production department and maintain facility cleanliness.

Minimum Requirements

• High school diploma required, PTEC (Process Technology) degree preferred
• 5 years' experience working in a manufacturing environment with technical background in Chemistry or Compressed Gases
• Proficient in manufacturing SAP transactions
• Ability to read and understand piping and instrumentation drawings and process flow charts
• Strong leadership skills with a results-oriented approach as well as the ability to train, motivate, and otherwise develop resources

Preferences:

• Prior exposure within a manufacturing environment subject to FDA regulations
• Knowledge of cGMPs and Good Documentation requirements
• Experience using ERP system such as SAP

Organizational Relationship/Scope:
Officially supervised by Manufacturing Area Supervisor.

Working Conditions:
Current work schedule is four 10-hour days per week, but subject to change. Work is mostly performed indoors. Occasional periods of work outdoors required. This is a 100% onsite role.
#LI-LM1
Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products.

Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs.

The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities.

The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit
Mallinckrodt Pharmaceuticals ("the Company") maintains a continuing policy of non-discrimination in employment.

The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law.

Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities.

This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e.

Open Payments) and certain state laws.