Job Information
Mallinckrodt Pharmaceuticals Sr. Project Engineer in Hobart, New York
Job Title
Sr. Project Engineer
Requisition
JR000014097 Sr. Project Engineer (Open)
Location
Hobart, NY (Pharma) - USA036
Additional Locations
Hobart, NY
Job Description
Works with respective functional group in developing and implementing project scope and cost estimates. Works with respective functional group(s), incorporating business data (sales, financial, etc.) where appropriate, to generate a compelling project justification and application for approval of funds. Works with all internal stakeholders to develop User Requirement Specifications (URS) for equipment. Assists Validation Department with developing, reviewing, approving and executing IQ, OQ, PQ, FAT, SAT, equivalency, change in kind documentation as required in the pharmaceutical environment while ensuring compliance to all applicable standards related to the technology including federal, state, and local regulatory codes, as well as customer, operations and corporate requirements. Execute change management process documentation. Manage the work of project contractors/vendors. Ensure proper end users training for all projects. Writes and executes Risk Analysis (i.e. FMEA and Fishbone Diagrams) and Engineering Change Orders. Utilizes continuous improvement methodology to improve internal processes. Writes/revises SOPs, User Requirement Specs, Functional Requirement Specs, Design Specs, Qualifications, etc. Provides engineering support to corrective actions and deviations by identifying root cause and offering solutions. When necessary, assist the Maintenance Department in resolving high-level technical processing issues related to equipment operation. When assigned act as Engineering Department representative on Site wide teams, e.g. safety. All other duties as assigned.
Education:
Bachelor’s degree in engineering discipline preferred, or equivalent technical experience as determined by the hiring manager.
Experience:
Four (4) plus years engineering experience in pharmaceutical manufacturing environment or other regulated industry.
Other Skills/Competencies:
Familiarity with ISPE accepted Good Engineering Practices, and scientific terms, principles and concepts required.
Ability to read & interpret AutoCAD electrical, mechanical schematics, P&ID drawings.
Experience with FDA, NFPA and OSHA codes and regulations.
Working knowledge of MS Word, Excel, PowerPoint, MS Project etc.
Able to work both independently, within a team, and able to organize and lead a team.
Strong organizational skills.
Strong verbal and written communications skills and ability to communicate clearly and efficiently.
Compensation Range: $75,988.00 – 103,580.00 + Bonus + Relocation Assistance + Benefits from day one + Generous 401K match.
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 www.mallinckrodt.com.
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.