Technical Specialist (Packaging Operations) 1

• Provide leadership for the introduction of new products, equipment, processes (including sterilization) & required qualification work needed for the Almac Pharma Services Production Department.
• Communicate closely with supporting departments which include facilities, engineering, and client services.
• Provide supervisory assistance within the production area as well as acting as the point person for production on project teams.

• Point person for projects providing effective feedback to the project team through regular project meetings.
• Communicate effectively with line manager and other department heads on issues and potential solutions.
• Control handover of process from initial phases to general production use. Ensure all relevant production staff are fully familiar and/or trained on the equipment, process & associated documentation.
• Provide clear and precise information regarding every facet of the process so it can be communicated to the client. This includes during any related audits/visits.
• Become technically proficient regarding the process, equipment and product enabling the individual to become a Subject Matter Expect.
• Ensure project timelines are adhered to and when issues arise escalate them appropriately.
• Responsible for Serialization of all New Product Introduction (NPI) activities, including completion of SOF/872 and Serialization PQs (SPQs).
• Support the delivery of an effective and efficient qualification and validation in accordance with Almac Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and customer specifications.
• Ensure compilation of all documentation (SOPs, Batch records, validation protocols or any other related documentation linked to the process) is accurate.

Required Education:

• A Bachelor’s degree or 3 years of work experience in Pharmaceutical, Food or Medical Device industries.

• Master’s degree

Required Work Experience:

• 2-3 years experience operating equipment in a primary role.
• Experience in leading a process such as the introduction of a new piece of equipment or product.
• 1 year supervisory or process Lead experience or project management experience within a pharmaceutical or regulated environment.
• Experience compiling technical documentation, e.g. SOP’s, Batch Records, Validation protocols, etc.
• Proven ability to work effectively on own initiative and within the boundaries of GMP and SOP’s.

Preferred experience:

• At least 1 year experience with pharmaceutical packaging equipment including but not limited to bottle filling, blister card packaging, vial & ampoule labelling, kit assembly and pouching operations.
• Blister forming experience.
• Bottle filling experience.
• Walleting and Vial labeling experience.

• Medical, Vision & Dental benefits from the 1st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Professional development programs/ continuous learning opportunities