Pharmaceutical Process Engineer
DOE Rochester, MI 48307
HKA Enterprises is currently seeking a highly motivated Process Engineer to support operations at a pharmaceutical site in Rochester, MI.
Direct and/or support feasibility line trials, engineering runs, batch documentation updates, validation studies, regulatory submission data, and commercial launch planning.
Liaison between project team and Operational functional leaders.
Assist the department managers with strategic initiatives and projects.
Specifying new equipment and processes needed to support ongoing manufacturing activities at the Rochester site.
Assume the role of the Customer Project Manager (CPM) on capital projects impacting the manufacturing area to ensure projects meet the agreed user requirements and are fit for use at the project completion.
Revise manufacturing batch records and procedures as needed.
Lead shop floor investigations and implement Corrective and Preventative Actions (CAPA’s).
Implement process improvements
Bachelor of Science Degree in Chemical Engineering is required.
Minimum of 5 years’ experience as project engineer, process engineer and/or project manager at an API cGMP facility.
PE or PMP is desired but not required
Solid understanding of engineering/design packages.
Experience with Pharmaceutical / FDA regulated processes, with a working knowledge of cGMP facility / equipment requirements in aseptic filling / packaging environments.
Demonstrates the ability to prepare and administer estimates, budgets, schedules, and the ability to manage multiple priorities.
Strong interpersonal, teamwork and problem solving skills.
Excellent verbal and written skills.
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.
Director of Recruiting
Anne Cleveland is the Director of Recruiting at HKA Enterprises. She specializes in recruiting for the pharmaceutical and power industries. Anne's advice to job seekers is "avoid having your resume fall into a black hole after applying by following up your online application with a quick phone call, text, or email directly to the recruiter listed on the job posting." The best way to reach Anne is via text or email.