- 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