Almac Group is currently seeking an Engineer (Packaging) for our Audubon, PA location. The Engineer (Packaging) will primarily be responsible for day to day activities within the engineering department to support Almac Pharma Services commercial packaging operations equipment-related projects.
Responsibilities include but are not limited to:
- Identify and mitigate packaging equipment issues for new business through strong engineering and process improvement methods, as well as support packaging processes for existing business.
- Work with a cross functional team to support new product launches and assist in the validation of new packaging equipment and processes.
- Provide technical support to investigations as well as ensure appropriate corrective and preventive actions are put in place.
- Provide training to the engineering and operational teams for new/modified packaging equipment.
- Adhere to agreed communication schedules and methods
- Escalate issues appropriately to line management and/or the project sponsor(s).
- Act as the primary point of contact for equipment / service providers (internal and external) for assigned projects.
- Attend factory testing of new equipment and support equipment installation and qualification on site (as required).
- Ensure corrective and preventive actions are completed in a timely manner.
- Assist with the generation, review, approval, and execution of validation / process documentation required to deliver assigned projects. Documents will include, but are not limited to:
- Validation strategies and plans.
- Validation protocols and reports.
- Tooling qualification.
- Equipment qualification documents (e.g. URS, DQ, IQ and OQ).
- Review and approval of vendor supplied documents.
- Client supplied overprinting specifications.
- Master Batch Records.
- Standard Operating Procedures.
- Controlled Reference Documents.
Required Experience / Education:
- Bachelor’s degree in Engineering
- 3 years experience in Engineering
- 1 year experience working within a quality system
- Demonstrated ability to communicate clearly (both written and spoken).
- Demonstrated ability to deliver results on time and in full.
- Demonstrated ability to apply sound engineering principles to troubleshoot and solve problems.
- Demonstrated ability to manage multiple priorities and work independently.
- Proven ability to work effectively on own initiative and within the boundaries of GMP and SOP’s.
- The ability to manage projects, present technical information to customers and work with customers and internal departments to drive project completion.
Preferred Experience / Education:
- 5 years experience in Engineering
- 2 years experience working within a quality system
- 2 years experience working within a regulated industry.
- 2 years experience with a combination of process, controls, and equipment engineering.
- 1 year experience with 21 CFR Part 11
- 1 year experience in equipment qualification
- PLC programming (various types), plant automation experience and electrical (low voltage/line drawings) experience preferred.
What Almac Group can offer YOU!
- Full medical, vision & dental benefits the 1st of the month after start date
- 20 days of PTO to start plus 12 holidays per year
- Company paid long and short term disability along with life insurance
- 401k company match
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing almost 7,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.