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Senior Pharmaceutical Project Manager

2 months ago

Port Washington, New York, United States ALK Full time
About ALK

ALK is a pioneering pharmaceutical company dedicated to revolutionizing the field of allergy treatment. With a rich history dating back to 1923, we have established ourselves as a leader in the development of innovative pharmaceutical products that target the root cause of allergies.

Our mission is to improve the quality of life for individuals suffering from allergies by creating effective treatments that induce a protective immune response. We are committed to advancing the field of allergy treatment through cutting-edge research and development.

Job Summary

We are seeking a highly skilled and experienced Senior Pharmaceutical Project Engineer to join our team in Port Washington, NY. The successful candidate will be responsible for managing the scope, deliverables, schedule, budget, and quality of engineering projects related to cGMP process equipment.

Key Responsibilities
  • Manage the design, site acceptance, and installation of equipment and critical utilities
  • Prepare and present project status reports
  • Manage design consultants for projects and assignments
  • Prepare drawings and documents related to projects
  • Support QA/validations through preparation of design documents and protocol review
  • Recommend and manage implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes
  • Evaluate, approve, prepare, and execute change controls and other QMS documentation
  • Act as Subject Matter Expert during regulatory inspections
  • Support manufacturing and maintenance activities as technical advisor
  • Maintain a clean and safe working environment by enforcing EHS policies and procedures
  • Maintain company reputation by enforcing compliance with local, state, and federal regulations
  • Provide technical guidance for fellow Engineering staff on projects
Requirements
  • Bachelor's degree or relevant experience in pharmaceutical engineering preferred
  • Formal training in project management preferred
  • 10+ years pharmaceutical project experience or equivalent combination of education and relevant experience
  • Demonstrate proficiency with industry project management practices and tools
  • Ability to analyze data and make conclusions based on the data
  • Able to work in a team across departments and sites
  • Clear understanding of other team members' roles and responsibilities
  • Ability to represent the department or organization in local and global projects with assistance from other cross-functional team members
  • Ability to work independently
  • Proven effective leadership abilities
  • Identifies opportunities for improvement and makes constructive suggestions for change to improve both project management and/or process effectiveness
  • Demonstrate initiative and good interpersonal skills, able to work in a team
  • Ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA
  • Must be able to travel domestically and internationally, as needed
  • Must be creative and flexible
  • Must have good attention to detail
  • Proven ability to understand and follow written and verbal instructions in English
  • Demonstrated ability to comply with required safety practices
  • Understanding of validation principles and applications for equipment and processes
Why ALK?

At ALK, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

ALK offers:

  • Excellent benefits including medical, dental, and vision
  • 401(k) plan with generous employer contribution
  • 13 company-paid holidays per year

ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.