Sr. Pharmaceutical Project Engineer

About ALK
ALK is a forward-thinking allergy company with a long tradition of allergy innovation. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) - a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.
Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees, and with subsidiaries, production facilities and distributors worldwide, we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and offices North America.
We are currently looking for a Full-Time Senior Pharmaceutical Project Engineer to join our teamin our Port Washington, NY site. The Sr. Pharmaceutical Project Engineer will work closely onsite with other departments and must be able to collaborate effectively with others to ensure that needs and specifications are met. This is a key position in our organization and the successful candidate must be able to communicate strategies clearly and effectively internally. The ideal candidate will be comfortable working in a fast-paced environment, can manage multiple site-specific projects, and feel comfortable leading when necessary.
Primary Responsibilities:
The primary responsibilities for this position include:

• Manages the scope, deliverables, schedule, budget and quality of engineering projects related to cGMP process equipment.
• Prepares and presents project status reports.
• Manages the design, site acceptance and installation of equipment and critical utilities
• Manages design consultants for projects and assignments
• Prepares drawings and documents related to projects.
• Supports QA/validations through preparation of design documents and protocol review.
• Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
• Experienced with the design, installation, and qualification of critical equipment, utilities, and facilities included WFI systems, Clean Steam, compressed air, aseptic filling/ processing, sterilization, and washing.
• Experience with design, installation and validation of building automation & environmental monitoring systems
• Evaluates, approves, prepares and executes change controls and other QMS documentation.
• Acts as Subject Matter Expert during regulatory inspections.
• Supports manufacturing and maintenance activities as technical advisor.
• Maintains clean and safe working environment by enforcing EHS policies and procedures.
• Maintains company reputation by enforcing compliance with local, state and federal regulations.
• Provides technical guidance for fellow Engineering staff on projects
• Other duties may be assigned.

Skills and Experience:

• 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

Approximate annual salary range for this role: $94,000 to $135,000. This salary range is an estimate in good faith for the position. Final compensation can vary based on the candidate's relevant experience, skills, and knowledge.
This position is not eligible for Visa Sponsorship.
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.